Trial Outcomes & Findings for Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus. (NCT NCT02849080)

NCT ID: NCT02849080

Last Updated: 2022-07-20

Results Overview

Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 504 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2022-07-20

Participant Flow

The main phase of the trial was conducted at 77 sites in 10 countries, and the extension phase (Switch) at 71 sites in 9 countries, as follows (main phase/extension phase): Argentina (3/3), Austria (3/3), Belgium (7/7), Brazil (2/0), Egypt (4/4), Norway (4/4), South Korea (7/7), Switzerland (8/5), Turkey (8/8), and United States (31/30).

The trial consisted of two treatment periods: a 52-week main phase and a 52-week extension phase. In Switch, participants were allowed to re-randomise from sitagliptin to oral semaglutide. Sustainability included results for participants who received oral semaglutide during main + extension phase.

Participant milestones

Measure	Oral Semaglutide Flex Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Oral Semaglutide Flex- Switch Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).	Sitagliptin 100 mg- Switch Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
Main Phase: 0 - 52 Weeks STARTED	253	251	0	0
Main Phase: 0 - 52 Weeks Exposed	253	250	0	0
Main Phase: 0 - 52 Weeks Full Analysis Set (FAS)	253	251	0	0
Main Phase: 0 - 52 Weeks Safety Analysis Set (SAS)	253	250	0	0
Main Phase: 0 - 52 Weeks COMPLETED	241	244	0	0
Main Phase: 0 - 52 Weeks NOT COMPLETED	12	7	0	0
Extension Phase: 53 - 104 Weeks STARTED	185	0	100	98
Extension Phase: 53 - 104 Weeks Exposed	184	0	100	97
Extension Phase: 53 - 104 Weeks COMPLETED	182	0	99	98
Extension Phase: 53 - 104 Weeks NOT COMPLETED	3	0	1	0

Reasons for withdrawal

Measure	Oral Semaglutide Flex Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Oral Semaglutide Flex- Switch Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).	Sitagliptin 100 mg- Switch Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
Main Phase: 0 - 52 Weeks Lost to Follow-up	7	4	0	0
Main Phase: 0 - 52 Weeks Withdrawal by Subject	5	1	0	0
Main Phase: 0 - 52 Weeks Death	0	2	0	0
Extension Phase: 53 - 104 Weeks Lost to Follow-up	2	0	0	0
Extension Phase: 53 - 104 Weeks Other	0	0	1	0
Extension Phase: 53 - 104 Weeks Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

Baseline characteristics by cohort

Measure	Oral Semaglutide Flex n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants who were still on treatment at week 52 were allowed to continue on oral semaglutide in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.	Sitagliptin 100 mg n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants who were still on treatment at week 52 were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial.	Total n=504 Participants Total of all reporting groups
Age, Continuous	57 Years STANDARD_DEVIATION 10 • n=5 Participants	58 Years STANDARD_DEVIATION 10 • n=7 Participants	57 Years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	111 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants	140 Participants n=7 Participants	285 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	48 Participants n=5 Participants	57 Participants n=7 Participants	105 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	205 Participants n=5 Participants	194 Participants n=7 Participants	399 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	195 Participants n=5 Participants	186 Participants n=7 Participants	381 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.

Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) On-treatment without rescue medication · No	73 Participants	132 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) In-trial · Yes	134 Participants	60 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) In-trial · No	96 Participants	178 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) On-treatment without rescue medication · Yes	123 Participants	52 Participants

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.

Change from baseline (week 0) in body weight was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Body Weight In-trial	-2.7 Kilogram (Kg) Standard Deviation 3.9	-0.7 Kilogram (Kg) Standard Deviation 3.5
Change in Body Weight On-treatment without rescue medication	-2.9 Kilogram (Kg) Standard Deviation 4.0	-0.9 Kilogram (Kg) Standard Deviation 3.6

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in HbA1c was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=230 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=238 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in HbA1c	-1.3 Percentage of HbA1c Standard Deviation 0.9	-0.8 Percentage of HbA1c Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=229 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=232 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in FPG	-2.41 Millimoles per liter (mmol/L) Standard Deviation 2.35	-1.39 Millimoles per liter (mmol/L) Standard Deviation 3.13

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Relative change from baseline (week 0) in body weight (kg) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=233 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=239 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Body Weight (%)	-2.99 Percentage change Standard Deviation 4.42	-0.76 Percentage change Standard Deviation 3.91

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=233 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=239 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in BMI	-1.0 Kilograms per square meter (kg/m^2) Standard Deviation 1.5	-0.3 Kilograms per square meter (kg/m^2) Standard Deviation 1.3

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=231 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=237 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Waist Circumference	-2.6 Centimeters (cm) Standard Deviation 5.3	-0.7 Centimeters (cm) Standard Deviation 5.1

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in total cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=226 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=234 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Total Cholesterol (Ratio to Baseline)	0.96 Ratio of total cholesterol Geometric Coefficient of Variation 19.3	1.01 Ratio of total cholesterol Geometric Coefficient of Variation 16.2

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=226 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=233 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in LDL Cholesterol (Ratio to Baseline)	0.97 Ratio of LDL cholesterol Geometric Coefficient of Variation 31.8	1.03 Ratio of LDL cholesterol Geometric Coefficient of Variation 27.2

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=226 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=233 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in HDL Cholesterol (Ratio to Baseline)	1.00 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.0	1.02 Ratio of HDL cholesterol Geometric Coefficient of Variation 16.5

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in triglycerides (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=226 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=233 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Triglycerides (Ratio to Baseline)	0.89 Ratio of triglycerides Geometric Coefficient of Variation 38.2	0.91 Ratio of triglycerides Geometric Coefficient of Variation 43.1

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Physical functioning	1.54 Score on a scale Standard Deviation 7.92	-0.03 Score on a scale Standard Deviation 7.16
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Role physical	0.40 Score on a scale Standard Deviation 7.82	0.13 Score on a scale Standard Deviation 8.38
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Bodily pain	1.09 Score on a scale Standard Deviation 9.01	1.20 Score on a scale Standard Deviation 8.72
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) General health	1.83 Score on a scale Standard Deviation 7.65	1.62 Score on a scale Standard Deviation 6.71
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Vitality	1.07 Score on a scale Standard Deviation 8.16	0.51 Score on a scale Standard Deviation 7.28
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Social functioning	0.38 Score on a scale Standard Deviation 9.00	0.41 Score on a scale Standard Deviation 7.86
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Role emotional	-0.91 Score on a scale Standard Deviation 11.71	-0.54 Score on a scale Standard Deviation 10.58
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Mental health	1.21 Score on a scale Standard Deviation 8.54	0.86 Score on a scale Standard Deviation 7.97
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) PCS	1.51 Score on a scale Standard Deviation 6.39	0.74 Score on a scale Standard Deviation 5.81
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) MCS	0.01 Score on a scale Standard Deviation 8.75	0.26 Score on a scale Standard Deviation 7.67

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.

Change from baseline (week 0) in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in DTSQ 1) Satisfaction with treatment	1.09 Score on a scale Standard Deviation 1.61	0.92 Score on a scale Standard Deviation 1.65
Change in DTSQ 2) Feeling of unacceptably high blood sugars	-1.58 Score on a scale Standard Deviation 2.13	-1.14 Score on a scale Standard Deviation 2.13
Change in DTSQ 3) Feeling of unacceptably low blood sugars	-0.15 Score on a scale Standard Deviation 1.70	-0.24 Score on a scale Standard Deviation 1.99
Change in DTSQ 4) Convenience of treatment	0.82 Score on a scale Standard Deviation 1.54	0.59 Score on a scale Standard Deviation 1.48
Change in DTSQ 5) Flexibility of current treatment	0.80 Score on a scale Standard Deviation 1.58	0.68 Score on a scale Standard Deviation 1.51
Change in DTSQ 6) Satisfaction with understanding of diabetes	0.77 Score on a scale Standard Deviation 1.51	0.77 Score on a scale Standard Deviation 1.71
Change in DTSQ 7) Recommending treatment to others	0.88 Score on a scale Standard Deviation 1.54	0.79 Score on a scale Standard Deviation 1.46
Change in DTSQ 8) Satisfaction to continue with present treatment	1.03 Score on a scale Standard Deviation 1.66	0.95 Score on a scale Standard Deviation 1.88
Change in DTSQ Total treatment satisfaction score	5.39 Score on a scale Standard Deviation 6.84	4.70 Score on a scale Standard Deviation 7.23

SECONDARY outcome

Timeframe: Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=230 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=238 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Yes	76 Participants	29 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) No	154 Participants	209 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=233 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=239 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve Weight Loss ≥5% (Yes/no) Yes	63 Participants	29 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) No	170 Participants	210 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=233 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=239 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve Weight Loss ≥10% (Yes/no) No	218 Participants	234 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) Yes	15 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 52 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=230 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=238 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Yes	104 Participants	35 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) No	126 Participants	203 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=230 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=238 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) No	150 Participants	213 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Yes	80 Participants	25 Participants

SECONDARY outcome

Timeframe: Weeks 0-52

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Time to Rescue Medication	8 Participants	40 Participants

SECONDARY outcome

Timeframe: Weeks 0-52

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=251 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Time to Additional Anti-diabetic Medication	22 Participants	47 Participants

SECONDARY outcome

Timeframe: Week 0-57

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=250 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Number of TEAEs During Exposure to Trial Product	768 Events	519 Events

SECONDARY outcome

Timeframe: Week 0-57

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=250 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes	34 Episodes	22 Episodes

SECONDARY outcome

Timeframe: Week 0-57

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=250 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in biochemical parameter- amylase (units per liter [U/L]) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=201 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=225 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Amylase (Ratio to Baseline)	1.14 Ratio of amylase Geometric Coefficient of Variation 25.5	1.08 Ratio of amylase Geometric Coefficient of Variation 26.3

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in lipase (U/L) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=201 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=225 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Lipase (Ratio to Baseline)	1.24 Ratio of lipase Geometric Coefficient of Variation 55.2	1.13 Ratio of lipase Geometric Coefficient of Variation 55.3

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in pulse rate was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=206 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=225 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Pulse Rate	3 Beats per minute Standard Deviation 9	0 Beats per minute Standard Deviation 10

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=206 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=225 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Systolic blood pressure	-3 Millimeters of mercury (mmHg) Standard Deviation 14	-2 Millimeters of mercury (mmHg) Standard Deviation 15
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Diastolic blood pressure	-0 Millimeters of mercury (mmHg) Standard Deviation 9	-1 Millimeters of mercury (mmHg) Standard Deviation 10

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=92 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=96 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in HbA1c- Switch	-0.2 Percentage of HbA1c Standard Deviation 1.2	0.0 Percentage of HbA1c Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in body weight was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=93 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Body Weight- Switch	-2.6 Kg Standard Deviation 3.8	-0.9 Kg Standard Deviation 5.4

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Relative change from week 52 in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=93 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Body Weight (%)- Switch	-3.12 Percentage change Standard Deviation 4.50	-0.70 Percentage change Standard Deviation 5.27

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=92 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=94 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in FPG- Switch	-0.35 Millimoles per liter (mmol/L) Standard Deviation 1.95	0.02 Millimoles per liter (mmol/L) Standard Deviation 2.31

SECONDARY outcome

Timeframe: Week 52, Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=93 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in BMI- Switch	-0.9 kg/m^2 Standard Deviation 1.4	-0.3 kg/m^2 Standard Deviation 2.2

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=93 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Waist Circumference- Switch	-1.8 Centimeters (cm) Standard Deviation 4.3	-0.9 Centimeters (cm) Standard Deviation 5.8

SECONDARY outcome

Timeframe: Week 104 (i.e., after 52 weeks of treatment in the extension phase)

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=92 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=96 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch Yes	44 Participants	26 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch No	48 Participants	70 Participants

SECONDARY outcome

Timeframe: Week 104 (i.e., after 52 weeks of treatment in the extension phase)

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=92 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=96 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch Yes	28 Participants	11 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch No	64 Participants	85 Participants

SECONDARY outcome

Timeframe: Week 104 (i.e., after 52 weeks of treatment in the extension phase)

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=93 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch Yes	31 Participants	12 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch No	62 Participants	85 Participants

SECONDARY outcome

Timeframe: Week 104 (i.e., after 52 weeks of treatment in the extension phase)

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c less than 7.0% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=92 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=96 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch Yes	36 Participants	18 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch No	56 Participants	78 Participants

SECONDARY outcome

Timeframe: Week 104 (i.e., after 52 weeks of treatment in the extension phase)

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) and no need for rescue medication (yes/no), was evaluated at week 104. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=92 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=96 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch	41 Participants	23 Participants

SECONDARY outcome

Timeframe: Weeks 53-104

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 53 to week 104. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after re-randomisation (week 52) and before (planned) end-of-treatment (week 104), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=100 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=98 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Time to Additional Anti-diabetic Medication- Switch	15 Participants	26 Participants

SECONDARY outcome

Timeframe: Weeks 53-104

Population: Overall number of participants analyzed = FAS which comprised all randomised participants.

Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 53 to week 104. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after re-randomisation (week 52) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=100 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=98 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Time to Rescue Medication- Switch	9 Participants	23 Participants

SECONDARY outcome

Timeframe: Week 53-109

Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent adverse events (TEAEs) were recorded from week 53 to week 109. Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=100 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Number of TEAEs During Exposure to Trial Product- Switch	267 Events	225 Events

SECONDARY outcome

Timeframe: Week 52, Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in biochemical parameter- amylase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=84 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=92 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Amylase (Ratio to Baseline)- Switch	1.09 Ratio of amylase Geometric Coefficient of Variation 22.9	1.00 Ratio of amylase Geometric Coefficient of Variation 26.6

SECONDARY outcome

Timeframe: Week 52, Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=84 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=92 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Lipase (Ratio to Baseline)- Switch	1.13 Ratio of lipase Geometric Coefficient of Variation 46.7	0.92 Ratio of lipase Geometric Coefficient of Variation 54.9

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=87 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=93 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Pulse Rate- Switch	1 Beats per minute Standard Deviation 9	-0 Beats per minute Standard Deviation 10

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from week 52 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=87 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=93 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch Systolic blood pressure	-3 Millimeters of mercury (mmHg) Standard Deviation 15	2 Millimeters of mercury (mmHg) Standard Deviation 15
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch Diastolic blood pressure	-1 Millimeters of mercury (mmHg) Standard Deviation 10	-0 Millimeters of mercury (mmHg) Standard Deviation 10

SECONDARY outcome

Timeframe: Week 53-109

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=100 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch	2 Episodes	12 Episodes

SECONDARY outcome

Timeframe: Week 53-109

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=100 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = number of participants with available data.

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from week 52 in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since week 52. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=93 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=97 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Mental health	0.37 Score on a scale Standard Deviation 6.68	0.20 Score on a scale Standard Deviation 6.46
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Physical functioning	1.14 Score on a scale Standard Deviation 8.55	-0.97 Score on a scale Standard Deviation 6.71
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Role physical	1.37 Score on a scale Standard Deviation 7.68	-0.22 Score on a scale Standard Deviation 7.61
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Bodily pain	-0.18 Score on a scale Standard Deviation 7.22	-0.30 Score on a scale Standard Deviation 7.06
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch General health	0.69 Score on a scale Standard Deviation 6.74	0.53 Score on a scale Standard Deviation 6.59
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Vitality	-0.18 Score on a scale Standard Deviation 6.91	-0.15 Score on a scale Standard Deviation 7.32
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Social functioning	0.21 Score on a scale Standard Deviation 7.36	0.10 Score on a scale Standard Deviation 6.54
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch Role emotional	1.72 Score on a scale Standard Deviation 9.61	-0.39 Score on a scale Standard Deviation 8.79
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch PCS	0.66 Score on a scale Standard Deviation 6.06	-0.43 Score on a scale Standard Deviation 5.36
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch MCS	0.52 Score on a scale Standard Deviation 7.21	0.19 Score on a scale Standard Deviation 6.46

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.

Change from week 52 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=100 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=98 Participants Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in DTSQ- Switch 1) Satisfaction with treatment	0.06 Score on a scale Standard Deviation 1.06	-0.24 Score on a scale Standard Deviation 1.43
Change in DTSQ- Switch 6) Satisfaction with understanding of diabetes	0.02 Score on a scale Standard Deviation 1.38	0.04 Score on a scale Standard Deviation 1.16
Change in DTSQ- Switch 2) Feeling of unacceptably high blood sugars	-0.32 Score on a scale Standard Deviation 1.95	0.09 Score on a scale Standard Deviation 2.04
Change in DTSQ- Switch 3) Feeling of unacceptably low blood sugars	0.02 Score on a scale Standard Deviation 1.63	0.23 Score on a scale Standard Deviation 1.94
Change in DTSQ- Switch 4) Convenience of treatment	0.13 Score on a scale Standard Deviation 1.18	0.13 Score on a scale Standard Deviation 1.16
Change in DTSQ- Switch 5) Flexibility of current treatment	0.01 Score on a scale Standard Deviation 1.19	0.06 Score on a scale Standard Deviation 1.22
Change in DTSQ- Switch 7) Recommending treatment to others	0.04 Score on a scale Standard Deviation 1.04	-0.05 Score on a scale Standard Deviation 1.20
Change in DTSQ- Switch 8) Satisfaction to continue with present treatment	-0.05 Score on a scale Standard Deviation 1.07	0.00 Score on a scale Standard Deviation 1.48
Change in DTSQ- Switch Total treatment satisfaction score	0.20 Score on a scale Standard Deviation 5.14	-0.06 Score on a scale Standard Deviation 5.62

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in HbA1c- Sustainability	-1.3 Percentage of HbA1c Standard Deviation 1.0	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in body weight was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Body Weight (kg)- Sustainability	-3.7 Kg Standard Deviation 5.2	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Relative change from baseline (week 0) in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Body Weight (%)- Sustainability	-4.03 Percentage change Standard Deviation 5.75	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=178 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in FPG- Sustainability	-39.4 Millimoles per liter (mmol/L) Standard Deviation 51.2	—

SECONDARY outcome

Timeframe: Week 0, Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in BMI- Sustainability	-1.3 kg/m^2 Standard Deviation 1.9	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=178 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Waist Circumference- Sustainability	-2.5 cm Standard Deviation 6.3	—

SECONDARY outcome

Timeframe: Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability Yes	101 Participants	—
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability No	79 Participants	—

SECONDARY outcome

Timeframe: Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability Yes	63 Participants	—
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability No	117 Participants	—

SECONDARY outcome

Timeframe: Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability Yes	61 Participants	—
Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability No	119 Participants	—

SECONDARY outcome

Timeframe: Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability Yes	73 Participants	—
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability No	107 Participants	—

SECONDARY outcome

Timeframe: Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Participants who achieved HbA1c <7.0% ADA target or HbA1c reduction ≥ 1%-point (10.9 mmol/mol) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability Yes	126 Participants	—
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability No	54 Participants	—

SECONDARY outcome

Timeframe: Week 0-109

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Number of TEAEs During Exposure to Trial Product- Sustainability	1157 Events	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in biochemical parameter- amylase (units per liter [U/L]) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=167 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Amylase (Ratio to Baseline)- Sustainability	1.13 Ratio of amylase Geometric Coefficient of Variation 25.1	—

SECONDARY outcome

Timeframe: Week 0, Week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=167 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Lipase (Ratio to Baseline)- Sustainability	1.18 Ratio of lipase Geometric Coefficient of Variation 58.0	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=176 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Pulse Rate- Sustainability	2 Beats per minute Standard Deviation 9	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=176 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability Systolic blood pressure	-3 Millimeters of mercury (mmHg) Standard Deviation 14	—
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability Diastolic blood pressure	-1 Millimeters of mercury (mmHg) Standard Deviation 9	—

SECONDARY outcome

Timeframe: Week 0-109

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability	45 Episodes	—

SECONDARY outcome

Timeframe: Week 0-109

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.

Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=253 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability	18 Participants	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = number of participants with available data.

Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Role physical	0.22 Score on a scale Standard Deviation 8.31	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability PCS	1.33 Score on a scale Standard Deviation 6.96	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability MCS	0.20 Score on a scale Standard Deviation 8.34	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Physical functioning	1.44 Score on a scale Standard Deviation 8.48	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Bodily pain	1.07 Score on a scale Standard Deviation 9.72	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability General health	1.98 Score on a scale Standard Deviation 8.01	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Vitality	0.97 Score on a scale Standard Deviation 8.49	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Social functioning	-0.11 Score on a scale Standard Deviation 8.14	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Role emotional	-0.04 Score on a scale Standard Deviation 10.49	—
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability Mental health	1.05 Score on a scale Standard Deviation 8.25	—

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.

Change from week 0 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide Flex- Main Phase n=180 Participants Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).
Change in DTSQ- Sustainability 2) Feeling of unacceptably high blood sugars	-1.46 Score on a scale Standard Deviation 2.44	—
Change in DTSQ- Sustainability 3) Feeling of unacceptably low blood sugars	-0.14 Score on a scale Standard Deviation 2.09	—
Change in DTSQ- Sustainability 5) Flexibility of current treatment	0.86 Score on a scale Standard Deviation 1.56	—
Change in DTSQ- Sustainability 6) Satisfaction with understanding of diabetes	0.84 Score on a scale Standard Deviation 1.50	—
Change in DTSQ- Sustainability 8) Satisfaction to continue with present treatment	1.11 Score on a scale Standard Deviation 1.62	—
Change in DTSQ- Sustainability Total treatment satisfaction score	5.81 Score on a scale Standard Deviation 7.11	—
Change in DTSQ- Sustainability 1) Satisfaction with treatment	1.19 Score on a scale Standard Deviation 1.61	—
Change in DTSQ- Sustainability 4) Convenience of treatment	0.88 Score on a scale Standard Deviation 1.52	—
Change in DTSQ- Sustainability 7) Recommending treatment to others	0.94 Score on a scale Standard Deviation 1.58	—

Adverse Events

Oral Semaglutide Flex- Main Phase

Serious events: 24 serious events

Other events: 126 other events

Deaths: 0 deaths

Sitagliptin 100 mg- Main Phase

Serious events: 24 serious events

Other events: 70 other events

Deaths: 2 deaths

Oral Semaglutide Flex- Sustainability

Serious events: 36 serious events

Other events: 148 other events

Deaths: 0 deaths

Oral Semaglutide Flex- Switch

Serious events: 9 serious events

Other events: 46 other events

Deaths: 0 deaths

Sitagliptin 100 mg- Switch

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral Semaglutide Flex- Main Phase n=253 participants at risk Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=250 participants at risk Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Oral Semaglutide Flex- Sustainability n=253 participants at risk Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104).	Oral Semaglutide Flex- Switch n=100 participants at risk Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).	Sitagliptin 100 mg- Switch n=97 participants at risk Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
Cardiac disorders Acute myocardial infarction	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.80% 2/250 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.79% 2/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.79% 2/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Angina unstable	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.79% 2/253 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Vascular disorders Aortic stenosis	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.80% 2/250 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Renal and urinary disorders Bladder prolapse	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Campylobacter gastroenteritis	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Cardiac failure chronic	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Eye disorders Cataract	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Investigations Catheterisation cardiac	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Coronary artery disease	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.79% 2/253 • Number of events 4 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Coronary artery insufficiency	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Respiratory, thoracic and mediastinal disorders Cough	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Psychiatric disorders Depression	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Escherichia pyelonephritis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Fall	0.79% 2/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.79% 2/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Femur fracture	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Gastric ulcer	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Hip fracture	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Metabolism and nutrition disorders Hyperglycaemia	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Ileus	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Inguinal hernia	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Intestinal mass	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.79% 2/253 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Nervous system disorders Ischaemic stroke	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
General disorders Malaise	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Myocardial ischaemia	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Psychiatric disorders Nightmare	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
General disorders Non-cardiac chest pain	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
General disorders Pain	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Vascular disorders Peripheral artery stenosis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Pyelonephritis	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
General disorders Pyrexia	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Renal and urinary disorders Renal colic	0.79% 2/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.79% 2/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Streptococcal sepsis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Renal and urinary disorders Ureterolithiasis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Abdominal pain	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Renal and urinary disorders Acute kidney injury	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Atrial fibrillation	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Cardiac disorders Cardiac failure congestive	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Surgical and medical procedures Cataract operation	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Diarrhoea	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Nervous system disorders Dizziness	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Surgical and medical procedures Gastric bypass	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Hiatus hernia	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Joint injury	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Injury, poisoning and procedural complications Laceration	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Eye disorders Macular fibrosis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Nervous system disorders Myelopathy	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Nausea	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.2% 3/253 • Number of events 4 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Otitis media chronic	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Ear and labyrinth disorders Otosclerosis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian endometrioid carcinoma	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Respiratory, thoracic and mediastinal disorders Pharyngeal polyp	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Surgical and medical procedures Shoulder operation	0.00% 0/253 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/250 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/253 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/100 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Other adverse events

Measure	Oral Semaglutide Flex- Main Phase n=253 participants at risk Participants were to receive oral semaglutide tablets once daily from week 0 to week 52 (main phase): 3 milligrams (mg) for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Sitagliptin 100 mg- Main Phase n=250 participants at risk Participants were to receive 100 mg sitagliptin tablet once daily for 52 weeks (main phase). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 52).	Oral Semaglutide Flex- Sustainability n=253 participants at risk Participants were to receive oral semaglutide tablets once daily for 104 weeks (week 0-52 in the main phase and week 53-104 in the extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 0 to week 104).	Oral Semaglutide Flex- Switch n=100 participants at risk Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to receive oral semaglutide tablets once daily from week 53 to week 104 (extension phase): 3 mg for the first 8 weeks, 3 or 7 mg for next 8 weeks followed by 3, 7 or 14 mg for the remaining treatment period. Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).	Sitagliptin 100 mg- Switch n=97 participants at risk Participants who were still on sitagliptin 100 mg treatment at week 52 (end of main phase) were re-randomised to continue sitagliptin in the extension phase (week 53 to week 104). Participants were to continue their anti-diabetic background medication (metformin, sulphonylurea, thiazolidinedione or sodium-glucose co-transporter 2 inhibitors) throughout the trial (week 53 to week 104).
Gastrointestinal disorders Abdominal pain upper	6.3% 16/253 • Number of events 17 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.2% 3/250 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.9% 20/253 • Number of events 27 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.0% 6/100 • Number of events 6 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Diarrhoea	8.7% 22/253 • Number of events 25 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.2% 8/250 • Number of events 11 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	11.5% 29/253 • Number of events 39 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	10.0% 10/100 • Number of events 11 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.1% 3/97 • Number of events 5 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Dyspepsia	5.1% 13/253 • Number of events 13 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.80% 2/250 • Number of events 4 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.1% 18/253 • Number of events 23 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.0% 4/100 • Number of events 4 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	2.1% 2/97 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Nervous system disorders Headache	9.9% 25/253 • Number of events 33 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.0% 15/250 • Number of events 15 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	11.5% 29/253 • Number of events 47 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.0% 4/100 • Number of events 4 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.1% 3/97 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Nasopharyngitis	10.3% 26/253 • Number of events 30 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.2% 13/250 • Number of events 15 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	13.4% 34/253 • Number of events 58 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.0% 7/100 • Number of events 8 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	10.3% 10/97 • Number of events 11 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Nausea	20.9% 53/253 • Number of events 83 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	2.4% 6/250 • Number of events 8 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	22.9% 58/253 • Number of events 113 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	17.0% 17/100 • Number of events 19 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.1% 3/97 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Upper respiratory tract infection	3.6% 9/253 • Number of events 9 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.0% 15/250 • Number of events 16 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.1% 18/253 • Number of events 33 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/100 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.1% 4/97 • Number of events 5 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Vomiting	5.5% 14/253 • Number of events 21 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.80% 2/250 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.1% 18/253 • Number of events 39 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.0% 7/100 • Number of events 8 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	2.1% 2/97 • Number of events 2 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 8/253 • Number of events 12 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.2% 8/250 • Number of events 9 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.7% 17/253 • Number of events 34 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.0% 3/100 • Number of events 5 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.1% 4/97 • Number of events 4 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Musculoskeletal and connective tissue disorders Back pain	3.6% 9/253 • Number of events 14 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.4% 11/250 • Number of events 14 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.7% 17/253 • Number of events 34 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.0% 3/100 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.2% 5/97 • Number of events 5 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Gastrointestinal disorders Constipation	2.8% 7/253 • Number of events 9 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	2.8% 7/250 • Number of events 8 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.3% 11/253 • Number of events 17 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.0% 5/100 • Number of events 5 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	1.0% 1/97 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Gastroenteritis	3.6% 9/253 • Number of events 9 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.40% 1/250 • Number of events 1 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.1% 13/253 • Number of events 19 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.0% 3/100 • Number of events 3 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.00% 0/97 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Infections and infestations Influenza	4.0% 10/253 • Number of events 11 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	2.4% 6/250 • Number of events 8 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.9% 15/253 • Number of events 23 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.0% 6/100 • Number of events 6 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.1% 4/97 • Number of events 5 • Week 0 to week 109. Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
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Restriction type: OTHER