Trial Outcomes & Findings for Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes (NCT NCT02607865)

NCT ID: NCT02607865

Last Updated: 2022-07-20

Results Overview

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. 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: 1864 participants
• Primary outcome timeframe: Week 0, week 26
• Results posted on: 2022-07-20

Participant Flow

The trial was conducted at 200 sites in 14 countries: Argentina-5, Brazil-1, France-10, Germany-12, Israel-8, Japan-16, Mexico-5, Romania-12, Russian Federation-8, South Africa-11, Turkey-7, Ukraine-8, United Kingdom (UK)-14, United States (US)-83. In addition, 6 sites screened, but didn't randomise any subjects: France-1, Turkey-1, UK-1 and US-3.

Data presented in "participant flow" is based on 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.

Participant milestones

Measure	Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Overall Study STARTED	466	466	465	467
Overall Study Full Analysis Set (FAS)	466	465	465	467
Overall Study Safety Analysis Set (SAS)	466	464	465	466
Overall Study COMPLETED	433	436	438	451
Overall Study NOT COMPLETED	33	30	27	16

Reasons for withdrawal

Measure	Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Overall Study Lost to Follow-up	9	7	7	5
Overall Study Withdrawal by Subject	18	18	17	8
Overall Study Death	5	4	1	3
Overall Study Unclassified	1	1	2	0

Baseline Characteristics

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Oral Semaglutide 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.	Total n=1863 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 10 • n=5 Participants	58 years STANDARD_DEVIATION 10 • n=7 Participants	57 years STANDARD_DEVIATION 10 • n=5 Participants	58 years STANDARD_DEVIATION 10 • n=4 Participants	58 years STANDARD_DEVIATION 10 • n=21 Participants
Sex: Female, Male Female	212 Participants n=5 Participants	220 Participants n=7 Participants	218 Participants n=5 Participants	229 Participants n=4 Participants	879 Participants n=21 Participants
Sex: Female, Male Male	254 Participants n=5 Participants	245 Participants n=7 Participants	247 Participants n=5 Participants	238 Participants n=4 Participants	984 Participants n=21 Participants
Race/Ethnicity, Customized White	344 Participants n=5 Participants	330 Participants n=7 Participants	317 Participants n=5 Participants	333 Participants n=4 Participants	1324 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	38 Participants n=5 Participants	38 Participants n=7 Participants	45 Participants n=5 Participants	39 Participants n=4 Participants	160 Participants n=21 Participants
Race/Ethnicity, Customized Asian	56 Participants n=5 Participants	69 Participants n=7 Participants	61 Participants n=5 Participants	59 Participants n=4 Participants	245 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	18 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other	13 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants	12 Participants n=4 Participants	56 Participants n=21 Participants
Race/Ethnicity, Customized Not applicable	5 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	8 Participants n=4 Participants	36 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	76 Participants n=5 Participants	77 Participants n=7 Participants	75 Participants n=5 Participants	93 Participants n=4 Participants	321 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	385 Participants n=5 Participants	378 Participants n=7 Participants	377 Participants n=5 Participants	366 Participants n=4 Participants	1506 Participants n=21 Participants
Glycosylated haemoglobin (HbA1c)	8.3 Percentage of HbA1c STANDARD_DEVIATION 1.0 • n=5 Participants	8.4 Percentage of HbA1c STANDARD_DEVIATION 1.0 • n=7 Participants	8.3 Percentage of HbA1c STANDARD_DEVIATION 0.9 • n=5 Participants	8.3 Percentage of HbA1c STANDARD_DEVIATION 0.9 • n=4 Participants	8.3 Percentage of HbA1c STANDARD_DEVIATION 0.9 • n=21 Participants

PRIMARY outcome

Timeframe: Week 0, week 26

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

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in HbA1c: Week 26 In-trial	-0.6 Percentage of HbA1c Standard Deviation 1.0	-1.1 Percentage of HbA1c Standard Deviation 1.1	-1.3 Percentage of HbA1c Standard Deviation 1.0	-0.8 Percentage of HbA1c Standard Deviation 0.9
Change in HbA1c: Week 26 On-treatment without rescue medication	-0.6 Percentage of HbA1c Standard Deviation 1.0	-1.2 Percentage of HbA1c Standard Deviation 1.1	-1.4 Percentage of HbA1c Standard Deviation 1.0	-0.8 Percentage of HbA1c Standard Deviation 0.9

SECONDARY outcome

Timeframe: Week 0, week 26

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 26. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Body Weight: Week 26 In-trial	-1.2 Kg Standard Deviation 3.2	-2.2 Kg Standard Deviation 3.9	-3.1 Kg Standard Deviation 3.8	-0.6 Kg Standard Deviation 3.2
Change in Body Weight: Week 26 on-treatment without rescue medication	-1.2 Kg Standard Deviation 3.3	-2.2 Kg Standard Deviation 4.0	-3.2 Kg Standard Deviation 3.8	-0.6 Kg Standard Deviation 3.2

SECONDARY outcome

Timeframe: Week 0, week 52, week 78

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 HbA1c was evaluated at weeks 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in HbA1c: Weeks 52 and 78 Week 52	-0.6 Percentage of HbA1c Standard Deviation 1.1	-1.0 Percentage of HbA1c Standard Deviation 1.2	-1.2 Percentage of HbA1c Standard Deviation 1.1	-0.7 Percentage of HbA1c Standard Deviation 1.1
Change in HbA1c: Weeks 52 and 78 Week 78	-0.6 Percentage of HbA1c Standard Deviation 1.1	-0.9 Percentage of HbA1c Standard Deviation 1.3	-1.1 Percentage of HbA1c Standard Deviation 1.1	-0.7 Percentage of HbA1c Standard Deviation 1.1

SECONDARY outcome

Timeframe: Week 0, week 52, week 78

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 weeks 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Body Weight (kg): Weeks 52 and 78 Week 52	-1.6 Kg Standard Deviation 4.1	-2.5 Kg Standard Deviation 4.9	-3.5 Kg Standard Deviation 4.7	-0.7 Kg Standard Deviation 3.7
Change in Body Weight (kg): Weeks 52 and 78 Week 78	-1.8 Kg Standard Deviation 4.9	-2.8 Kg Standard Deviation 5.4	-3.2 Kg Standard Deviation 4.9	-1.0 Kg Standard Deviation 4.1

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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

Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Body Weight (%) Week 26	-1.23 Percentage change Standard Deviation 3.57	-2.36 Percentage change Standard Deviation 4.09	-3.44 Percentage change Standard Deviation 4.21	-0.64 Percentage change Standard Deviation 3.38
Change in Body Weight (%) Week 52	-1.65 Percentage change Standard Deviation 4.28	-2.63 Percentage change Standard Deviation 5.09	-3.83 Percentage change Standard Deviation 5.14	-0.76 Percentage change Standard Deviation 3.91
Change in Body Weight (%) Week 78	-1.87 Percentage change Standard Deviation 4.87	-2.92 Percentage change Standard Deviation 5.67	-3.47 Percentage change Standard Deviation 5.34	-0.99 Percentage change Standard Deviation 4.39

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in FPG Week 26	-0.83 mmol/L Standard Deviation 2.69	-1.17 mmol/L Standard Deviation 2.54	-1.67 mmol/L Standard Deviation 2.60	-0.90 mmol/L Standard Deviation 2.32
Change in FPG Week 52	-0.98 mmol/L Standard Deviation 2.78	-1.28 mmol/L Standard Deviation 2.62	-1.75 mmol/L Standard Deviation 2.57	-1.03 mmol/L Standard Deviation 2.60
Change in FPG Week 78	-1.07 mmol/L Standard Deviation 3.21	-1.11 mmol/L Standard Deviation 2.92	-1.65 mmol/L Standard Deviation 2.71	-0.91 mmol/L Standard Deviation 2.59

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 mass index (BMI) was evaluated at weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in BMI Week 26	-0.4 Kg/m^2 Standard Deviation 1.2	-0.8 Kg/m^2 Standard Deviation 1.4	-1.1 Kg/m^2 Standard Deviation 1.4	-0.2 Kg/m^2 Standard Deviation 1.1
Change in BMI Week 52	-0.6 Kg/m^2 Standard Deviation 1.5	-0.9 Kg/m^2 Standard Deviation 1.7	-1.2 Kg/m^2 Standard Deviation 1.7	-0.3 Kg/m^2 Standard Deviation 1.3
Change in BMI Week 78	-0.7 Kg/m^2 Standard Deviation 1.8	-1.0 Kg/m^2 Standard Deviation 1.9	-1.1 Kg/m^2 Standard Deviation 1.7	-0.4 Kg/m^2 Standard Deviation 1.5

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 waist circumference was evaluated at weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Waist Circumference Week 26	-0.7 cm Standard Deviation 5.0	-1.8 cm Standard Deviation 5.2	-2.3 cm Standard Deviation 5.2	-0.6 cm Standard Deviation 4.4
Change in Waist Circumference Week 52	-1.3 cm Standard Deviation 5.7	-2.3 cm Standard Deviation 6.8	-2.6 cm Standard Deviation 6.2	-0.5 cm Standard Deviation 5.1
Change in Waist Circumference Week 78	-1.2 cm Standard Deviation 6.0	-2.4 cm Standard Deviation 7.2	-2.4 cm Standard Deviation 6.1	-0.7 cm Standard Deviation 5.6

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 total 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Total Cholesterol (Ratio to Baseline) Week 78	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 18.3	0.99 Ratio of total cholesterol Geometric Coefficient of Variation 19.3	0.99 Ratio of total cholesterol Geometric Coefficient of Variation 18.7	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 19.4
Change in Total Cholesterol (Ratio to Baseline) Week 26	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 16.8	0.98 Ratio of total cholesterol Geometric Coefficient of Variation 17.5	0.97 Ratio of total cholesterol Geometric Coefficient of Variation 17.1	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 16.4
Change in Total Cholesterol (Ratio to Baseline) Week 52	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 17.5	0.99 Ratio of total cholesterol Geometric Coefficient of Variation 18.5	0.98 Ratio of total cholesterol Geometric Coefficient of Variation 17.0	1.01 Ratio of total cholesterol Geometric Coefficient of Variation 16.9

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 low-density lipoprotein (LDL) 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in LDL Cholesterol (Ratio to Baseline) Week 78	1.03 Ratio of LDL cholesterol Geometric Coefficient of Variation 30.8	1.00 Ratio of LDL cholesterol Geometric Coefficient of Variation 30.2	1.00 Ratio of LDL cholesterol Geometric Coefficient of Variation 30.2	1.03 Ratio of LDL cholesterol Geometric Coefficient of Variation 32.6
Change in LDL Cholesterol (Ratio to Baseline) Week 26	1.02 Ratio of LDL cholesterol Geometric Coefficient of Variation 28.2	0.98 Ratio of LDL cholesterol Geometric Coefficient of Variation 28.0	0.98 Ratio of LDL cholesterol Geometric Coefficient of Variation 28.6	1.02 Ratio of LDL cholesterol Geometric Coefficient of Variation 26.4
Change in LDL Cholesterol (Ratio to Baseline) Week 52	1.02 Ratio of LDL cholesterol Geometric Coefficient of Variation 28.1	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 29.7	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 27.4	1.03 Ratio of LDL cholesterol Geometric Coefficient of Variation 27.7

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 very-low-density lipoprotein (VLDL) 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in VLDL Cholesterol (Ratio to Baseline) Week 26	0.99 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.4	0.96 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.1	0.91 Ratio of VLDL cholesterol Geometric Coefficient of Variation 36.3	0.97 Ratio of VLDL cholesterol Geometric Coefficient of Variation 34.1
Change in VLDL Cholesterol (Ratio to Baseline) Week 52	1.00 Ratio of VLDL cholesterol Geometric Coefficient of Variation 35.0	0.98 Ratio of VLDL cholesterol Geometric Coefficient of Variation 39.1	0.93 Ratio of VLDL cholesterol Geometric Coefficient of Variation 39.6	0.98 Ratio of VLDL cholesterol Geometric Coefficient of Variation 34.4
Change in VLDL Cholesterol (Ratio to Baseline) Week 78	0.95 Ratio of VLDL cholesterol Geometric Coefficient of Variation 41.7	0.94 Ratio of VLDL cholesterol Geometric Coefficient of Variation 41.5	0.91 Ratio of VLDL cholesterol Geometric Coefficient of Variation 40.4	0.94 Ratio of VLDL cholesterol Geometric Coefficient of Variation 39.6

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in HDL Cholesterol (Ratio to Baseline) Week 26	0.97 Ratio of HDL cholesterol Geometric Coefficient of Variation 13.6	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.8	0.98 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.9	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 12.6
Change in HDL Cholesterol (Ratio to Baseline) Week 52	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 13.9	1.01 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.3	1.01 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.2	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.9
Change in HDL Cholesterol (Ratio to Baseline) Week 78	0.97 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.3	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.6	1.00 Ratio of HDL cholesterol Geometric Coefficient of Variation 15.5	0.99 Ratio of HDL cholesterol Geometric Coefficient of Variation 14.2

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 triglycerides (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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Triglycerides (Ratio to Baseline) Week 26	0.99 Ratio of triglycerides Geometric Coefficient of Variation 38.1	0.96 Ratio of triglycerides Geometric Coefficient of Variation 39.2	0.92 Ratio of triglycerides Geometric Coefficient of Variation 39.8	0.97 Ratio of triglycerides Geometric Coefficient of Variation 36.2
Change in Triglycerides (Ratio to Baseline) Week 52	1.00 Ratio of triglycerides Geometric Coefficient of Variation 35.7	0.97 Ratio of triglycerides Geometric Coefficient of Variation 41.3	0.93 Ratio of triglycerides Geometric Coefficient of Variation 42.3	0.98 Ratio of triglycerides Geometric Coefficient of Variation 37.8
Change in Triglycerides (Ratio to Baseline) Week 78	0.95 Ratio of triglycerides Geometric Coefficient of Variation 43.9	0.94 Ratio of triglycerides Geometric Coefficient of Variation 43.7	0.92 Ratio of triglycerides Geometric Coefficient of Variation 43.1	0.93 Ratio of triglycerides Geometric Coefficient of Variation 41.6

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 free fatty acids (FFA) (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. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here.

Outcome measures

Measure	Oral Semaglutide 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Free Fatty Acids (Ratio to Baseline) Week 26	0.96 Ratio of FFA Geometric Coefficient of Variation 48.7	0.91 Ratio of FFA Geometric Coefficient of Variation 50.4	0.88 Ratio of FFA Geometric Coefficient of Variation 55.8	0.90 Ratio of FFA Geometric Coefficient of Variation 49.8
Change in Free Fatty Acids (Ratio to Baseline) Week 52	1.03 Ratio of FFA Geometric Coefficient of Variation 46.7	1.00 Ratio of FFA Geometric Coefficient of Variation 47.9	0.96 Ratio of FFA Geometric Coefficient of Variation 56.0	0.98 Ratio of FFA Geometric Coefficient of Variation 47.5
Change in Free Fatty Acids (Ratio to Baseline) Week 78	0.92 Ratio of FFA Geometric Coefficient of Variation 54.2	0.87 Ratio of FFA Geometric Coefficient of Variation 56.5	0.88 Ratio of FFA Geometric Coefficient of Variation 56.3	0.87 Ratio of FFA Geometric Coefficient of Variation 57.8

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in SMPG - Mean 7-point Profile Week 26	-1.1 mmol/L Standard Deviation 2.3	-1.5 mmol/L Standard Deviation 2.3	-1.7 mmol/L Standard Deviation 2.4	-1.2 mmol/L Standard Deviation 2.3
Change in SMPG - Mean 7-point Profile Week 52	-1.3 mmol/L Standard Deviation 2.4	-1.5 mmol/L Standard Deviation 2.5	-1.8 mmol/L Standard Deviation 2.4	-1.4 mmol/L Standard Deviation 2.4
Change in SMPG - Mean 7-point Profile Week 78	-1.3 mmol/L Standard Deviation 2.7	-1.5 mmol/L Standard Deviation 2.7	-1.7 mmol/L Standard Deviation 2.2	-1.3 mmol/L Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 the average of the post-prandial increments over all meals was evaluated at weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in SMPG - Mean Postprandial Increment Over All Meals Week 26	-0.4 mmol/L Standard Deviation 2.1	-0.4 mmol/L Standard Deviation 2.1	-0.6 mmol/L Standard Deviation 2.1	-0.6 mmol/L Standard Deviation 2.1
Change in SMPG - Mean Postprandial Increment Over All Meals Week 52	-0.4 mmol/L Standard Deviation 2.0	-0.4 mmol/L Standard Deviation 2.1	-0.7 mmol/L Standard Deviation 2.0	-0.4 mmol/L Standard Deviation 2.1
Change in SMPG - Mean Postprandial Increment Over All Meals Week 78	-0.4 mmol/L Standard Deviation 2.1	-0.4 mmol/L Standard Deviation 2.1	-0.6 mmol/L Standard Deviation 2.0	-0.6 mmol/L Standard Deviation 2.2

SECONDARY outcome

Timeframe: Week 26, week 52, week 78

Population: Overall number of participants analyzed = 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 weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 26 · Yes	116 Participants	192 Participants	246 Participants	144 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 26 · No	319 Participants	246 Participants	190 Participants	302 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 52 · Yes	113 Participants	168 Participants	238 Participants	138 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 52 · No	314 Participants	263 Participants	196 Participants	298 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 78 · Yes	113 Participants	165 Participants	191 Participants	129 Participants
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) Week 78 · No	308 Participants	259 Participants	234 Participants	310 Participants

SECONDARY outcome

Timeframe: Week 26, week 52, week 78

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number 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 weeks 26, 52 and 78 are 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Week 26 · Yes	55 Participants	116 Participants	161 Participants	61 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Week 26 · No	380 Participants	322 Participants	275 Participants	385 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Week 52 · Yes	55 Participants	99 Participants	146 Participants	59 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Week 52 · No	372 Participants	332 Participants	288 Participants	377 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Week 78 · Yes	49 Participants	100 Participants	129 Participants	60 Participants
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) Week 78 · No	372 Participants	324 Participants	296 Participants	379 Participants

SECONDARY outcome

Timeframe: Week 26, week 52, week 78

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number 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 26, 52 and 78 are 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants Who Achieve Weight Loss ≥5% (Yes/no) Week 26 · Yes	53 Participants	81 Participants	131 Participants	45 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) Week 26 · No	385 Participants	359 Participants	308 Participants	402 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) Week 52 · Yes	66 Participants	118 Participants	147 Participants	50 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) Week 52 · No	362 Participants	315 Participants	288 Participants	387 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) Week 78 · Yes	83 Participants	115 Participants	139 Participants	59 Participants
Participants Who Achieve Weight Loss ≥5% (Yes/no) Week 78 · No	342 Participants	310 Participants	289 Participants	384 Participants

SECONDARY outcome

Timeframe: Week 26, week 52, week 78

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number 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 weeks 26, 52 and 78 are 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants Who Achieve Weight Loss ≥10% (Yes/no) Week 26 · Yes	5 Participants	23 Participants	29 Participants	8 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) Week 26 · No	433 Participants	417 Participants	410 Participants	439 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) Week 52 · Yes	13 Participants	31 Participants	48 Participants	11 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) Week 52 · No	415 Participants	402 Participants	387 Participants	426 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) Week 78 · Yes	12 Participants	43 Participants	46 Participants	17 Participants
Participants Who Achieve Weight Loss ≥10% (Yes/no) Week 78 · No	413 Participants	382 Participants	382 Participants	426 Participants

SECONDARY outcome

Timeframe: Week 26, week 52, week 78

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number 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 weeks 26, 52 and 78 are 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Week 26 · Yes	87 Participants	155 Participants	208 Participants	90 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Week 26 · No	348 Participants	283 Participants	228 Participants	356 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Week 52 · Yes	87 Participants	134 Participants	195 Participants	87 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Week 52 · No	340 Participants	297 Participants	239 Participants	349 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Week 78 · Yes	85 Participants	136 Participants	151 Participants	84 Participants
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) Week 78 · No	336 Participants	288 Participants	274 Participants	355 Participants

SECONDARY outcome

Timeframe: Week 26, week 52, week 78

Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number 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 weeks 26, 52 and 78 are 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Week 26 · Yes	55 Participants	117 Participants	166 Participants	43 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Week 26 · No	380 Participants	321 Participants	270 Participants	403 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Week 52 · Yes	73 Participants	106 Participants	164 Participants	51 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Week 52 · No	354 Participants	325 Participants	270 Participants	385 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Week 78 · Yes	76 Participants	113 Participants	149 Participants	60 Participants
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) Week 78 · No	345 Participants	311 Participants	276 Participants	379 Participants

SECONDARY outcome

Timeframe: Weeks 0-78

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 periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. 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 78), 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Time to Additional Anti-diabetic Medication Week 0 to week 26	33 Participants	20 Participants	15 Participants	20 Participants
Time to Additional Anti-diabetic Medication Week 0 to week 52	137 Participants	86 Participants	51 Participants	111 Participants
Time to Additional Anti-diabetic Medication Week 0 to week 78	179 Participants	119 Participants	75 Participants	148 Participants

SECONDARY outcome

Timeframe: Weeks 0-78

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 26, week 0 to week 52 and week 0 to week 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Time to Rescue Medication Week 0 to week 26	25 Participants	11 Participants	5 Participants	13 Participants
Time to Rescue Medication Week 0 to week 52	121 Participants	73 Participants	31 Participants	94 Participants
Time to Rescue Medication Week 0 to week 78	160 Participants	103 Participants	47 Participants	129 Participants

SECONDARY outcome

Timeframe: Weeks 0-83

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 83 (78-week treatment period 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Number of TEAEs During Exposure to Trial Product	1774 Events	1686 Events	1824 Events	1852 Events

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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

Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Amylase (Ratio to Baseline) Week 26	1.03 Ratio Geometric Coefficient of Variation 25.6	1.07 Ratio Geometric Coefficient of Variation 27.5	1.14 Ratio Geometric Coefficient of Variation 30.4	1.08 Ratio Geometric Coefficient of Variation 21.4
Change in Amylase (Ratio to Baseline) Week 52	1.03 Ratio Geometric Coefficient of Variation 25.8	1.09 Ratio Geometric Coefficient of Variation 28.8	1.11 Ratio Geometric Coefficient of Variation 29.0	1.08 Ratio Geometric Coefficient of Variation 24.1
Change in Amylase (Ratio to Baseline) Week 78	1.02 Ratio Geometric Coefficient of Variation 28.4	1.09 Ratio Geometric Coefficient of Variation 29.2	1.09 Ratio Geometric Coefficient of Variation 25.5	1.08 Ratio Geometric Coefficient of Variation 25.9

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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

Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Lipase (Ratio to Baseline) Week 26	1.07 Ratio Geometric Coefficient of Variation 52.6	1.13 Ratio Geometric Coefficient of Variation 60.1	1.26 Ratio Geometric Coefficient of Variation 64.9	1.14 Ratio Geometric Coefficient of Variation 50.3
Change in Lipase (Ratio to Baseline) Week 52	1.06 Ratio Geometric Coefficient of Variation 51.5	1.15 Ratio Geometric Coefficient of Variation 59.4	1.25 Ratio Geometric Coefficient of Variation 56.6	1.15 Ratio Geometric Coefficient of Variation 54.2
Change in Lipase (Ratio to Baseline) Week 78	1.04 Ratio Geometric Coefficient of Variation 56.2	1.14 Ratio Geometric Coefficient of Variation 61.9	1.18 Ratio Geometric Coefficient of Variation 54.3	1.10 Ratio Geometric Coefficient of Variation 50.7

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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

Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Pulse Rate Week 26	1 Beats/minute Standard Deviation 9	2 Beats/minute Standard Deviation 9	3 Beats/minute Standard Deviation 10	0 Beats/minute Standard Deviation 10
Change in Pulse Rate Week 52	0 Beats/minute Standard Deviation 10	2 Beats/minute Standard Deviation 9	2 Beats/minute Standard Deviation 10	-0 Beats/minute Standard Deviation 10
Change in Pulse Rate Week 78	1 Beats/minute Standard Deviation 10	1 Beats/minute Standard Deviation 10	2 Beats/minute Standard Deviation 10	0 Beats/minute Standard Deviation 10

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number 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 weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in SBP and DBP SBP: Week 26	-2 mmHg Standard Deviation 14	-2 mmHg Standard Deviation 15	-3 mmHg Standard Deviation 14	-2 mmHg Standard Deviation 15
Change in SBP and DBP SBP: Week 52	-2 mmHg Standard Deviation 15	-4 mmHg Standard Deviation 14	-3 mmHg Standard Deviation 15	-1 mmHg Standard Deviation 14
Change in SBP and DBP SBP: Week 78	-2 mmHg Standard Deviation 15	-3 mmHg Standard Deviation 15	-3 mmHg Standard Deviation 14	0 mmHg Standard Deviation 15
Change in SBP and DBP DBP: Week 26	-1 mmHg Standard Deviation 9	-0 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 9	-0 mmHg Standard Deviation 9
Change in SBP and DBP DBP: Week 52	-2 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 9	-1 mmHg Standard Deviation 9
Change in SBP and DBP DBP: Week 78	-1 mmHg Standard Deviation 10	-1 mmHg Standard Deviation 10	-1 mmHg Standard Deviation 10	-1 mmHg Standard Deviation 10

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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

Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in ECG Evaluation Normal (week 0) to normal (week 26)	211 Participants	214 Participants	230 Participants	204 Participants
Change in ECG Evaluation Normal (week 0) to abnormal NCS (week 26)	38 Participants	42 Participants	24 Participants	41 Participants
Change in ECG Evaluation Normal (week 0) to abnormal CS (week 26)	4 Participants	5 Participants	0 Participants	4 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to normal (week 26)	41 Participants	44 Participants	42 Participants	40 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal NCS (week 26)	132 Participants	128 Participants	133 Participants	143 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal CS (week 26)	4 Participants	1 Participants	1 Participants	3 Participants
Change in ECG Evaluation Abnormal (week 0) CS to normal (week 26)	1 Participants	1 Participants	0 Participants	3 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal NCS (week 26)	3 Participants	2 Participants	3 Participants	2 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal CS (week 26)	4 Participants	2 Participants	6 Participants	4 Participants
Change in ECG Evaluation Normal (week 0) to normal (week 52)	196 Participants	218 Participants	219 Participants	204 Participants
Change in ECG Evaluation Normal (week 0) to abnormal NCS (week 52)	47 Participants	37 Participants	33 Participants	40 Participants
Change in ECG Evaluation Normal (week 0) to abnormal CS (week 52)	1 Participants	0 Participants	1 Participants	4 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to normal (week 52)	40 Participants	49 Participants	56 Participants	48 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal NCS (week 52)	131 Participants	123 Participants	118 Participants	128 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal CS (week 52)	4 Participants	1 Participants	0 Participants	2 Participants
Change in ECG Evaluation Abnormal (week 0) CS to normal (week 52)	1 Participants	1 Participants	2 Participants	1 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal NCS (week 52)	3 Participants	3 Participants	0 Participants	2 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal CS (week 52)	4 Participants	1 Participants	7 Participants	6 Participants
Change in ECG Evaluation Normal (week 0) to normal (week 78)	196 Participants	201 Participants	219 Participants	208 Participants
Change in ECG Evaluation Normal (week 0) to abnormal NCS (week 78)	41 Participants	43 Participants	31 Participants	40 Participants
Change in ECG Evaluation Normal (week 0) to abnormal CS (week 78)	3 Participants	2 Participants	1 Participants	1 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to normal (week 78)	39 Participants	45 Participants	51 Participants	47 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal NCS (week 78)	131 Participants	125 Participants	114 Participants	133 Participants
Change in ECG Evaluation Abnormal (week 0) NCS to abnormal CS (week 78)	5 Participants	1 Participants	3 Participants	2 Participants
Change in ECG Evaluation Abnormal (week 0) CS to normal (week 78)	0 Participants	3 Participants	1 Participants	3 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal NCS (week 78)	4 Participants	2 Participants	3 Participants	2 Participants
Change in ECG Evaluation Abnormal (week 0) CS to abnormal CS (week 78)	4 Participants	1 Participants	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Week -2, week 52, week 78

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

Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 are 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. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.

Outcome measures

Measure	Oral Semaglutide 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 52) · Abnormal NCS	39 Participants	28 Participants	36 Participants	40 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 52) · Abnormal CS	1 Participants	3 Participants	2 Participants	2 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 78) · Normal	398 Participants	387 Participants	393 Participants	408 Participants
Change in Physical Examination 1) Cardiovascular system (week -2) · Normal	431 Participants	425 Participants	432 Participants	424 Participants
Change in Physical Examination 1) Cardiovascular system (week -2) · Abnormal NCS	30 Participants	38 Participants	30 Participants	41 Participants
Change in Physical Examination 1) Cardiovascular system (week -2) · Abnormal CS	5 Participants	1 Participants	3 Participants	1 Participants
Change in Physical Examination 1) Cardiovascular system (week 52) · Normal	398 Participants	396 Participants	404 Participants	399 Participants
Change in Physical Examination 1) Cardiovascular system (week 52) · Abnormal NCS	24 Participants	36 Participants	28 Participants	37 Participants
Change in Physical Examination 1) Cardiovascular system (week 52) · Abnormal CS	5 Participants	1 Participants	3 Participants	0 Participants
Change in Physical Examination 1) Cardiovascular system (week 78) · Normal	395 Participants	386 Participants	402 Participants	399 Participants
Change in Physical Examination 1) Cardiovascular system (week 78) · Abnormal NCS	24 Participants	33 Participants	24 Participants	41 Participants
Change in Physical Examination 1) Cardiovascular system (week 78) · Abnormal CS	5 Participants	4 Participants	2 Participants	1 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week -2) · Normal	410 Participants	415 Participants	407 Participants	409 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week -2) · Abnormal NCS	44 Participants	42 Participants	49 Participants	43 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week -2) · Abnormal CS	12 Participants	6 Participants	8 Participants	14 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 52) · Normal	376 Participants	382 Participants	388 Participants	385 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 52) · Abnormal NCS	44 Participants	45 Participants	38 Participants	42 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 52) · Abnormal CS	7 Participants	6 Participants	9 Participants	8 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 78) · Normal	377 Participants	376 Participants	384 Participants	399 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 78) · Abnormal NCS	43 Participants	43 Participants	37 Participants	37 Participants
Change in Physical Examination 2) Central and peripheral nervous system (week 78) · Abnormal CS	4 Participants	4 Participants	7 Participants	5 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week -2) · Normal	419 Participants	421 Participants	420 Participants	421 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week -2) · Abnormal NCS	45 Participants	39 Participants	45 Participants	45 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week -2) · Abnormal CS	2 Participants	4 Participants	0 Participants	0 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 52) · Normal	386 Participants	402 Participants	397 Participants	394 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 78) · Abnormal NCS	26 Participants	31 Participants	35 Participants	31 Participants
Change in Physical Examination 3) Gastrointestinal system, incl. mouth (week 78) · Abnormal CS	0 Participants	5 Participants	0 Participants	2 Participants
Change in Physical Examination 4) General appearance (week -2) · Normal	407 Participants	405 Participants	412 Participants	405 Participants
Change in Physical Examination 4) General appearance (week -2) · Abnormal NCS	43 Participants	45 Participants	38 Participants	46 Participants
Change in Physical Examination 7) Musculoskeletal system (week 78) · Abnormal NCS	33 Participants	31 Participants	24 Participants	23 Participants
Change in Physical Examination 4) General appearance (week -2) · Abnormal CS	16 Participants	14 Participants	15 Participants	15 Participants
Change in Physical Examination 4) General appearance (week 52) · Normal	381 Participants	384 Participants	390 Participants	385 Participants
Change in Physical Examination 4) General appearance (week 52) · Abnormal NCS	37 Participants	37 Participants	33 Participants	39 Participants
Change in Physical Examination 4) General appearance (week 52) · Abnormal CS	8 Participants	12 Participants	12 Participants	12 Participants
Change in Physical Examination 4) General appearance (week 78) · Normal	379 Participants	373 Participants	388 Participants	394 Participants
Change in Physical Examination 4) General appearance (week 78) · Abnormal NCS	37 Participants	40 Participants	28 Participants	37 Participants
Change in Physical Examination 4) General appearance (week 78) · Abnormal CS	8 Participants	10 Participants	12 Participants	10 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week -2) · Normal	441 Participants	440 Participants	435 Participants	444 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week -2) · Abnormal NCS	25 Participants	24 Participants	27 Participants	21 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week -2) · Abnormal CS	0 Participants	0 Participants	3 Participants	1 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week 52) · Normal	398 Participants	411 Participants	404 Participants	410 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week 52) · Abnormal NCS	25 Participants	21 Participants	27 Participants	26 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week 52) · Abnormal CS	3 Participants	1 Participants	4 Participants	0 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week 78) · Normal	400 Participants	405 Participants	399 Participants	415 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week 78) · Abnormal NCS	22 Participants	17 Participants	28 Participants	25 Participants
Change in Physical Examination 5) Head, ears, eyes, nose, throat, neck (week 78) · Abnormal CS	2 Participants	1 Participants	1 Participants	1 Participants
Change in Physical Examination 6) Lymph node palpation (week -2) · Normal	466 Participants	462 Participants	463 Participants	464 Participants
Change in Physical Examination 6) Lymph node palpation (week -2) · Abnormal NCS	0 Participants	1 Participants	2 Participants	2 Participants
Change in Physical Examination 6) Lymph node palpation (week -2) · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (week 52) · Normal	425 Participants	432 Participants	434 Participants	436 Participants
Change in Physical Examination 6) Lymph node palpation (week 52) · Abnormal NCS	1 Participants	1 Participants	1 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (week 52) · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (week 78) · Normal	421 Participants	423 Participants	425 Participants	441 Participants
Change in Physical Examination 6) Lymph node palpation (week 78) · Abnormal NCS	2 Participants	0 Participants	3 Participants	0 Participants
Change in Physical Examination 6) Lymph node palpation (week 78) · Abnormal CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination 7) Musculoskeletal system (week 78) · Abnormal CS	3 Participants	3 Participants	2 Participants	5 Participants
Change in Physical Examination 7) Musculoskeletal system (week -2) · Normal	421 Participants	435 Participants	440 Participants	430 Participants
Change in Physical Examination 7) Musculoskeletal system (week -2) · Abnormal NCS	39 Participants	24 Participants	23 Participants	32 Participants
Change in Physical Examination 7) Musculoskeletal system (week -2) · Abnormal CS	6 Participants	5 Participants	2 Participants	4 Participants
Change in Physical Examination 7) Musculoskeletal system (week 52) · Normal	383 Participants	400 Participants	408 Participants	403 Participants
Change in Physical Examination 7) Musculoskeletal system (week 52) · Abnormal NCS	37 Participants	28 Participants	24 Participants	26 Participants
Change in Physical Examination 7) Musculoskeletal system (week 52) · Abnormal CS	6 Participants	5 Participants	3 Participants	6 Participants
Change in Physical Examination 7) Musculoskeletal system (week 78) · Normal	388 Participants	389 Participants	402 Participants	413 Participants
Change in Physical Examination 8) Respiratory system (week -2) · Normal	458 Participants	451 Participants	462 Participants	456 Participants
Change in Physical Examination 8) Respiratory system (week -2) · Abnormal NCS	6 Participants	9 Participants	2 Participants	10 Participants
Change in Physical Examination 8) Respiratory system (week -2) · Abnormal CS	2 Participants	4 Participants	1 Participants	0 Participants
Change in Physical Examination 8) Respiratory system (week 52) · Normal	418 Participants	427 Participants	431 Participants	429 Participants
Change in Physical Examination 8) Respiratory system (week 52) · Abnormal NCS	6 Participants	4 Participants	3 Participants	6 Participants
Change in Physical Examination 8) Respiratory system (week 52) · Abnormal CS	2 Participants	2 Participants	1 Participants	1 Participants
Change in Physical Examination 8) Respiratory system (week 78) · Normal	419 Participants	418 Participants	427 Participants	434 Participants
Change in Physical Examination 8) Respiratory system (week 78) · Abnormal NCS	3 Participants	4 Participants	1 Participants	6 Participants
Change in Physical Examination 8) Respiratory system (week 78) · Abnormal CS	2 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination 9) Skin (week -2) · Normal	394 Participants	400 Participants	394 Participants	402 Participants
Change in Physical Examination 9) Skin (week -2) · Abnormal NCS	66 Participants	56 Participants	61 Participants	58 Participants
Change in Physical Examination 9) Skin (week -2) · Abnormal CS	6 Participants	8 Participants	10 Participants	6 Participants
Change in Physical Examination 9) Skin (week 52) · Normal	372 Participants	383 Participants	383 Participants	375 Participants
Change in Physical Examination 9) Skin (week 52) · Abnormal NCS	52 Participants	44 Participants	44 Participants	51 Participants
Change in Physical Examination 9) Skin (week 52) · Abnormal CS	3 Participants	6 Participants	8 Participants	10 Participants
Change in Physical Examination 9) Skin (week 78) · Normal	361 Participants	370 Participants	382 Participants	393 Participants
Change in Physical Examination 9) Skin (week 78) · Abnormal NCS	55 Participants	45 Participants	38 Participants	41 Participants
Change in Physical Examination 9) Skin (week 78) · Abnormal CS	8 Participants	8 Participants	8 Participants	7 Participants
Change in Physical Examination 10) Thyroid gland (week -2) · Normal	451 Participants	452 Participants	451 Participants	454 Participants
Change in Physical Examination 10) Thyroid gland (week -2) · Abnormal NCS	13 Participants	11 Participants	11 Participants	12 Participants
Change in Physical Examination 10) Thyroid gland (week -2) · Abnormal CS	1 Participants	1 Participants	3 Participants	0 Participants
Change in Physical Examination 10) Thyroid gland (week 52) · Normal	413 Participants	423 Participants	425 Participants	427 Participants
Change in Physical Examination 10) Thyroid gland (week 52) · Abnormal NCS	11 Participants	10 Participants	7 Participants	8 Participants
Change in Physical Examination 10) Thyroid gland (week 52) · Abnormal CS	2 Participants	0 Participants	3 Participants	1 Participants
Change in Physical Examination 10) Thyroid gland (week 78) · Normal	411 Participants	411 Participants	418 Participants	433 Participants
Change in Physical Examination 10) Thyroid gland (week 78) · Abnormal NCS	11 Participants	12 Participants	8 Participants	7 Participants
Change in Physical Examination 10) Thyroid gland (week 78) · Abnormal CS	2 Participants	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week -2, week 52, week 78

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

Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 are 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in Eye Examination Category Left eye (week -2) · Normal	302 Participants	299 Participants	305 Participants	297 Participants
Change in Eye Examination Category Left eye (week -2) · Abnormal NCS	130 Participants	138 Participants	129 Participants	137 Participants
Change in Eye Examination Category Left eye (week -2) · Abnormal CS	27 Participants	18 Participants	23 Participants	29 Participants
Change in Eye Examination Category Left eye (week 52) · Normal	249 Participants	253 Participants	270 Participants	252 Participants
Change in Eye Examination Category Left eye (week 52) · Abnormal NCS	119 Participants	113 Participants	101 Participants	126 Participants
Change in Eye Examination Category Left eye (week 52) · Abnormal CS	25 Participants	22 Participants	20 Participants	27 Participants
Change in Eye Examination Category Left eye (week 78) · Normal	261 Participants	255 Participants	273 Participants	287 Participants
Change in Eye Examination Category Left eye (week 78) · Abnormal NCS	135 Participants	141 Participants	130 Participants	113 Participants
Change in Eye Examination Category Left eye (week 78) · Abnormal CS	21 Participants	19 Participants	17 Participants	31 Participants
Change in Eye Examination Category Right eye (week -2) · Normal	309 Participants	298 Participants	308 Participants	297 Participants
Change in Eye Examination Category Right eye (week -2) · Abnormal NCS	126 Participants	139 Participants	126 Participants	138 Participants
Change in Eye Examination Category Right eye (week -2) · Abnormal CS	24 Participants	17 Participants	23 Participants	28 Participants
Change in Eye Examination Category Right eye (week 52) · Normal	247 Participants	256 Participants	271 Participants	255 Participants
Change in Eye Examination Category Right eye (week 52) · Abnormal NCS	122 Participants	112 Participants	103 Participants	123 Participants
Change in Eye Examination Category Right eye (week 52) · Abnormal CS	24 Participants	20 Participants	17 Participants	27 Participants
Change in Eye Examination Category Right eye (week 78) · Normal	258 Participants	255 Participants	275 Participants	279 Participants
Change in Eye Examination Category Right eye (week 78) · Abnormal NCS	136 Participants	146 Participants	128 Participants	122 Participants
Change in Eye Examination Category Right eye (week 78) · Abnormal CS	23 Participants	14 Participants	17 Participants	30 Participants

SECONDARY outcome

Timeframe: Weeks 0-83

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

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) are 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 3 mg n=459 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=460 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)	1 Participants	2 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-83

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

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) are 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 3 mg n=459 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=460 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-83

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

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-83) are 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 3 mg n=459 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=460 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)	0 Participants	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-83

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

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) are 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 3 mg n=459 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=460 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Weeks 0-83

Population: Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). 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 3 mg n=1 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=2 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=3 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Anti-semaglutide Binding Antibody Levels Week 4	—	—	9.82 %B/T Standard Deviation 0	—
Anti-semaglutide Binding Antibody Levels Week 8	1.93 %B/T Standard Deviation 0	—	—	—
Anti-semaglutide Binding Antibody Levels Week 14	—	3.28 %B/T Standard Deviation 0	—	—
Anti-semaglutide Binding Antibody Levels Week 26	—	2.39 %B/T Standard Deviation 0	2.05 %B/T Standard Deviation 0	—
Anti-semaglutide Binding Antibody Levels Week 38	—	—	2.24 %B/T Standard Deviation 0	—

SECONDARY outcome

Timeframe: Weeks 0-83

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 0-83 (78-week treatment period 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 subject 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes	56 Episodes	42 Episodes	60 Episodes	76 Episodes

SECONDARY outcome

Timeframe: Weeks 0-83

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 from week 0 to week 83 (78-week treatment period 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 subject 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes	23 Participants	24 Participants	36 Participants	39 Participants

SECONDARY outcome

Timeframe: Weeks 0-83

Population: Overall number of participants analysed = number of participants in the PK subpopulation. Number Analyzed = number of participants with available data in the PK subpopulation.

This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period 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 3 mg n=221 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=215 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=205 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 0	0.4 nmol/L Geometric Coefficient of Variation 0.0	0.4 nmol/L Geometric Coefficient of Variation 0.0	0.4 nmol/L Geometric Coefficient of Variation 0.0	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 4	1.5 nmol/L Geometric Coefficient of Variation 109.3	1.5 nmol/L Geometric Coefficient of Variation 102.1	1.6 nmol/L Geometric Coefficient of Variation 109.1	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 8	1.5 nmol/L Geometric Coefficient of Variation 103.9	4.1 nmol/L Geometric Coefficient of Variation 129.4	4.2 nmol/L Geometric Coefficient of Variation 128.0	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 14	1.4 nmol/L Geometric Coefficient of Variation 111.8	4.0 nmol/L Geometric Coefficient of Variation 146.8	9.4 nmol/L Geometric Coefficient of Variation 156.6	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 26	1.3 nmol/L Geometric Coefficient of Variation 104.5	3.7 nmol/L Geometric Coefficient of Variation 122.5	8.6 nmol/L Geometric Coefficient of Variation 162.2	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 38	1.4 nmol/L Geometric Coefficient of Variation 107.8	3.5 nmol/L Geometric Coefficient of Variation 106.4	8.6 nmol/L Geometric Coefficient of Variation 163.0	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 52	1.4 nmol/L Geometric Coefficient of Variation 105.8	3.5 nmol/L Geometric Coefficient of Variation 119.0	8.2 nmol/L Geometric Coefficient of Variation 167.0	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 78	1.3 nmol/L Geometric Coefficient of Variation 115.3	3.5 nmol/L Geometric Coefficient of Variation 127.2	8.9 nmol/L Geometric Coefficient of Variation 152.7	—
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses Week 83	0.4 nmol/L Geometric Coefficient of Variation 10.3	0.4 nmol/L Geometric Coefficient of Variation 16.5	0.4 nmol/L Geometric Coefficient of Variation 42.6	—

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 weeks 26, 52 and 78. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 6) Social functioning (week 78)	-0.38 Score on a scale Standard Deviation 8.29	0.19 Score on a scale Standard Deviation 8.77	-0.27 Score on a scale Standard Deviation 8.66	0.57 Score on a scale Standard Deviation 8.93
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 7) Role emotional (week 26)	0.84 Score on a scale Standard Deviation 10.47	0.67 Score on a scale Standard Deviation 9.18	-0.37 Score on a scale Standard Deviation 9.77	0.15 Score on a scale Standard Deviation 9.97
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 7) Role emotional (week 52)	0.15 Score on a scale Standard Deviation 10.99	-0.45 Score on a scale Standard Deviation 11.89	-0.86 Score on a scale Standard Deviation 10.65	-0.63 Score on a scale Standard Deviation 10.33
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 7) Role emotional (week 78)	0.32 Score on a scale Standard Deviation 10.98	0.23 Score on a scale Standard Deviation 10.95	-0.30 Score on a scale Standard Deviation 11.00	-0.24 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) 8) Mental health (week 26)	0.33 Score on a scale Standard Deviation 8.32	0.24 Score on a scale Standard Deviation 8.17	0.24 Score on a scale Standard Deviation 8.14	0.61 Score on a scale Standard Deviation 8.03
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 8) Mental health (week 52)	0.45 Score on a scale Standard Deviation 8.02	0.42 Score on a scale Standard Deviation 9.11	0.05 Score on a scale Standard Deviation 7.99	0.23 Score on a scale Standard Deviation 8.20
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 8) Mental health (week 78)	0.19 Score on a scale Standard Deviation 9.08	0.29 Score on a scale Standard Deviation 9.33	0.28 Score on a scale Standard Deviation 8.87	0.30 Score on a scale Standard Deviation 9.33
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 component summary (week 26)	0.56 Score on a scale Standard Deviation 6.42	0.98 Score on a scale Standard Deviation 5.72	0.63 Score on a scale Standard Deviation 6.00	0.69 Score on a scale Standard Deviation 6.24
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 component summary (week 52)	0.31 Score on a scale Standard Deviation 6.50	0.36 Score on a scale Standard Deviation 6.82	0.09 Score on a scale Standard Deviation 6.47	0.31 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) Physical component summary (week 78)	0.46 Score on a scale Standard Deviation 6.74	0.71 Score on a scale Standard Deviation 6.24	0.67 Score on a scale Standard Deviation 6.29	0.70 Score on a scale Standard Deviation 6.38
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Mental component summary (week 26)	0.48 Score on a scale Standard Deviation 8.62	0.34 Score on a scale Standard Deviation 8.26	0.08 Score on a scale Standard Deviation 8.18	0.41 Score on a scale Standard Deviation 8.16
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Mental component summary (week 52)	0.23 Score on a scale Standard Deviation 8.41	-0.00 Score on a scale Standard Deviation 9.43	-0.37 Score on a scale Standard Deviation 8.64	-0.31 Score on a scale Standard Deviation 8.71
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) Mental component summary (week 78)	0.27 Score on a scale Standard Deviation 9.18	0.23 Score on a scale Standard Deviation 9.50	-0.07 Score on a scale Standard Deviation 9.31	0.30 Score on a scale Standard Deviation 9.46
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 1) Physical functioning (week 26)	0.37 Score on a scale Standard Deviation 7.25	1.12 Score on a scale Standard Deviation 6.52	0.63 Score on a scale Standard Deviation 7.13	0.46 Score on a scale Standard Deviation 6.73
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 1) Physical functioning (week 52)	0.29 Score on a scale Standard Deviation 7.14	0.64 Score on a scale Standard Deviation 7.34	0.36 Score on a scale Standard Deviation 7.30	0.06 Score on a scale Standard Deviation 7.30
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 1) Physical functioning (week 78)	0.06 Score on a scale Standard Deviation 8.09	0.94 Score on a scale Standard Deviation 6.91	0.54 Score on a scale Standard Deviation 7.98	0.09 Score on a scale Standard Deviation 7.60
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 2) Role-Physical (week 26)	0.42 Score on a scale Standard Deviation 7.85	0.76 Score on a scale Standard Deviation 7.15	-0.13 Score on a scale Standard Deviation 7.59	0.38 Score on a scale Standard Deviation 8.00
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 2) Role-Physical (week 52)	-0.05 Score on a scale Standard Deviation 8.40	-0.06 Score on a scale Standard Deviation 9.42	-0.82 Score on a scale Standard Deviation 8.49	-0.69 Score on a scale Standard Deviation 8.08
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 2) Role-Physical (week 78)	0.28 Score on a scale Standard Deviation 8.14	-0.01 Score on a scale Standard Deviation 8.40	-0.33 Score on a scale Standard Deviation 7.57	0.44 Score on a scale Standard Deviation 7.96
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 3) Bodily pain (week 26)	0.56 Score on a scale Standard Deviation 9.20	-0.11 Score on a scale Standard Deviation 8.60	0.22 Score on a scale Standard Deviation 9.02	0.44 Score on a scale Standard Deviation 9.18
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 3) Bodily pain (week 52)	0.16 Score on a scale Standard Deviation 9.44	-0.65 Score on a scale Standard Deviation 9.92	-0.64 Score on a scale Standard Deviation 9.40	0.67 Score on a scale Standard Deviation 8.93
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 3) Bodily pain (week 78)	0.48 Score on a scale Standard Deviation 9.24	0.32 Score on a scale Standard Deviation 8.85	0.74 Score on a scale Standard Deviation 9.40	0.54 Score on a scale Standard Deviation 9.44
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 4) General health (week 26)	1.17 Score on a scale Standard Deviation 6.50	1.67 Score on a scale Standard Deviation 6.98	1.19 Score on a scale Standard Deviation 7.00	1.42 Score on a scale Standard Deviation 7.02
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 4) General health (week 52)	1.06 Score on a scale Standard Deviation 7.07	1.20 Score on a scale Standard Deviation 7.08	1.03 Score on a scale Standard Deviation 6.88	0.95 Score on a scale Standard Deviation 7.38
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 4) General health (week 78)	1.02 Score on a scale Standard Deviation 7.23	1.21 Score on a scale Standard Deviation 7.60	1.21 Score on a scale Standard Deviation 7.62	1.32 Score on a scale Standard Deviation 7.99
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 5) Vitality (week 26)	0.59 Score on a scale Standard Deviation 7.28	1.11 Score on a scale Standard Deviation 7.30	0.88 Score on a scale Standard Deviation 7.42	1.03 Score on a scale Standard Deviation 7.42
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 5) Vitality (week 52)	0.45 Score on a scale Standard Deviation 7.50	0.79 Score on a scale Standard Deviation 8.33	0.58 Score on a scale Standard Deviation 8.15	0.19 Score on a scale Standard Deviation 7.73
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 5) Vitality (week 78)	1.05 Score on a scale Standard Deviation 8.06	0.85 Score on a scale Standard Deviation 7.92	0.71 Score on a scale Standard Deviation 8.42	1.07 Score on a scale Standard Deviation 8.27
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) 6) Social functioning (week 26)	0.11 Score on a scale Standard Deviation 7.93	0.15 Score on a scale Standard Deviation 8.03	0.31 Score on a scale Standard Deviation 7.33	0.09 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) 6) Social functioning (week 52)	-0.25 Score on a scale Standard Deviation 8.35	-0.37 Score on a scale Standard Deviation 9.39	-0.83 Score on a scale Standard Deviation 8.83	-0.68 Score on a scale Standard Deviation 9.23

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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

The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. 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 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 1) Physical (week 26)	3.25 Score on a scale Standard Deviation 14.81	2.38 Score on a scale Standard Deviation 14.87	2.87 Score on a scale Standard Deviation 17.32	1.97 Score on a scale Standard Deviation 15.07
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 1) Physical (week 52)	1.84 Score on a scale Standard Deviation 15.80	3.03 Score on a scale Standard Deviation 16.32	3.18 Score on a scale Standard Deviation 18.40	1.49 Score on a scale Standard Deviation 16.11
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 1) Physical (week 78)	2.71 Score on a scale Standard Deviation 16.16	3.55 Score on a scale Standard Deviation 16.47	3.86 Score on a scale Standard Deviation 17.37	2.86 Score on a scale Standard Deviation 17.55
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 2) Physical function (week 26)	3.52 Score on a scale Standard Deviation 16.48	2.78 Score on a scale Standard Deviation 16.13	3.20 Score on a scale Standard Deviation 18.48	1.70 Score on a scale Standard Deviation 16.54
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 2) Physical function (week 52)	2.28 Score on a scale Standard Deviation 17.00	3.24 Score on a scale Standard Deviation 18.17	3.19 Score on a scale Standard Deviation 19.76	1.22 Score on a scale Standard Deviation 18.21
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 2) Physical function (week 78)	2.55 Score on a scale Standard Deviation 17.86	4.04 Score on a scale Standard Deviation 17.99	3.76 Score on a scale Standard Deviation 18.78	2.54 Score on a scale Standard Deviation 18.96
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 3) Pain/discomfort (week 26)	2.51 Score on a scale Standard Deviation 20.28	1.37 Score on a scale Standard Deviation 21.34	2.03 Score on a scale Standard Deviation 22.10	2.66 Score on a scale Standard Deviation 21.27
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 3) Pain/discomfort (week 52)	0.76 Score on a scale Standard Deviation 22.31	2.52 Score on a scale Standard Deviation 22.04	3.15 Score on a scale Standard Deviation 23.29	2.12 Score on a scale Standard Deviation 21.73
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 3) Pain/discomfort (week 78)	3.06 Score on a scale Standard Deviation 20.39	2.35 Score on a scale Standard Deviation 22.66	4.07 Score on a scale Standard Deviation 22.28	3.63 Score on a scale Standard Deviation 22.38
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 4) Psychosocial (week 26)	2.69 Score on a scale Standard Deviation 13.32	4.30 Score on a scale Standard Deviation 15.05	2.98 Score on a scale Standard Deviation 14.86	2.10 Score on a scale Standard Deviation 13.21
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 4) Psychosocial (week 52)	3.12 Score on a scale Standard Deviation 14.55	5.19 Score on a scale Standard Deviation 15.04	3.97 Score on a scale Standard Deviation 16.46	2.53 Score on a scale Standard Deviation 14.09
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains 4) Psychosocial (week 78)	3.83 Score on a scale Standard Deviation 14.89	5.36 Score on a scale Standard Deviation 15.62	3.73 Score on a scale Standard Deviation 16.22	3.29 Score on a scale Standard Deviation 14.53
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains IWQOL-Lite-CT Total (week 26)	2.88 Score on a scale Standard Deviation 12.11	3.62 Score on a scale Standard Deviation 13.37	2.95 Score on a scale Standard Deviation 13.87	2.05 Score on a scale Standard Deviation 12.05
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains IWQOL-Lite-CT Total (week 52)	2.67 Score on a scale Standard Deviation 13.01	4.43 Score on a scale Standard Deviation 13.59	3.64 Score on a scale Standard Deviation 15.22	2.17 Score on a scale Standard Deviation 12.86
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains IWQOL-Lite-CT Total (week 78)	3.45 Score on a scale Standard Deviation 13.32	4.73 Score on a scale Standard Deviation 14.07	3.77 Score on a scale Standard Deviation 14.97	3.16 Score on a scale Standard Deviation 13.76

SECONDARY outcome

Timeframe: Week 0, week 26, week 52, week 78

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 Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.

Outcome measures

Measure	Oral Semaglutide 3 mg n=466 Participants Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 Participants Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=467 Participants Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Change in CoEQ: Scores From the 4 Domains and the 19 Items 1) Feeling of hunger (wk 26)	-0.41 Score on a scale Standard Deviation 2.61	-0.37 Score on a scale Standard Deviation 2.58	-0.54 Score on a scale Standard Deviation 2.58	-0.18 Score on a scale Standard Deviation 2.49
Change in CoEQ: Scores From the 4 Domains and the 19 Items 1) Feeling of hunger (wk 52)	-0.28 Score on a scale Standard Deviation 2.50	-0.23 Score on a scale Standard Deviation 2.69	-0.35 Score on a scale Standard Deviation 2.65	-0.25 Score on a scale Standard Deviation 2.39
Change in CoEQ: Scores From the 4 Domains and the 19 Items 1) Feeling of hunger (wk 78)	-0.31 Score on a scale Standard Deviation 2.56	-0.22 Score on a scale Standard Deviation 2.73	-0.36 Score on a scale Standard Deviation 2.52	-0.22 Score on a scale Standard Deviation 2.55
Change in CoEQ: Scores From the 4 Domains and the 19 Items 2) Feeling of fullness (wk 26)	-0.08 Score on a scale Standard Deviation 2.66	-0.08 Score on a scale Standard Deviation 2.77	0.15 Score on a scale Standard Deviation 2.66	0.15 Score on a scale Standard Deviation 2.45
Change in CoEQ: Scores From the 4 Domains and the 19 Items 2) Feeling of fullness (wk 52)	-0.02 Score on a scale Standard Deviation 2.61	-0.07 Score on a scale Standard Deviation 2.64	0.22 Score on a scale Standard Deviation 2.68	0.27 Score on a scale Standard Deviation 2.67
Change in CoEQ: Scores From the 4 Domains and the 19 Items 2) Feeling of fullness (wk 78)	-0.03 Score on a scale Standard Deviation 2.59	-0.09 Score on a scale Standard Deviation 2.71	0.09 Score on a scale Standard Deviation 2.74	0.26 Score on a scale Standard Deviation 2.59
Change in CoEQ: Scores From the 4 Domains and the 19 Items 3) Desire to eat sweet foods (wk 26)	-0.41 Score on a scale Standard Deviation 2.55	-0.54 Score on a scale Standard Deviation 3.02	-0.47 Score on a scale Standard Deviation 2.98	-0.33 Score on a scale Standard Deviation 2.92
Change in CoEQ: Scores From the 4 Domains and the 19 Items 3) Desire to eat sweet foods (wk 52)	-0.31 Score on a scale Standard Deviation 2.74	-0.31 Score on a scale Standard Deviation 2.97	-0.31 Score on a scale Standard Deviation 3.02	-0.45 Score on a scale Standard Deviation 2.75
Change in CoEQ: Scores From the 4 Domains and the 19 Items 3) Desire to eat sweet foods (wk 78)	-0.38 Score on a scale Standard Deviation 2.51	-0.42 Score on a scale Standard Deviation 3.02	-0.45 Score on a scale Standard Deviation 2.97	-0.49 Score on a scale Standard Deviation 2.84
Change in CoEQ: Scores From the 4 Domains and the 19 Items 4) Desire to eat savoury foods (wk 26)	-0.27 Score on a scale Standard Deviation 2.48	-0.16 Score on a scale Standard Deviation 2.88	-0.30 Score on a scale Standard Deviation 3.03	-0.35 Score on a scale Standard Deviation 2.74
Change in CoEQ: Scores From the 4 Domains and the 19 Items 4) Desire to eat savoury foods (wk 52)	-0.27 Score on a scale Standard Deviation 2.78	-0.21 Score on a scale Standard Deviation 2.80	-0.44 Score on a scale Standard Deviation 2.94	-0.33 Score on a scale Standard Deviation 2.70
Change in CoEQ: Scores From the 4 Domains and the 19 Items 4) Desire to eat savoury foods (wk 78)	-0.39 Score on a scale Standard Deviation 2.64	-0.39 Score on a scale Standard Deviation 2.95	-0.39 Score on a scale Standard Deviation 2.80	-0.42 Score on a scale Standard Deviation 2.81
Change in CoEQ: Scores From the 4 Domains and the 19 Items 5) Feeling of happiness (wk 26)	0.01 Score on a scale Standard Deviation 2.22	0.03 Score on a scale Standard Deviation 2.11	0.04 Score on a scale Standard Deviation 2.22	0.13 Score on a scale Standard Deviation 2.21
Change in CoEQ: Scores From the 4 Domains and the 19 Items 5) Feeling of happiness (wk 52)	0.09 Score on a scale Standard Deviation 2.25	0.04 Score on a scale Standard Deviation 2.21	0.09 Score on a scale Standard Deviation 2.15	0.14 Score on a scale Standard Deviation 2.16
Change in CoEQ: Scores From the 4 Domains and the 19 Items 5) Feeling of happiness (wk 78)	-0.05 Score on a scale Standard Deviation 2.32	-0.08 Score on a scale Standard Deviation 2.21	0.04 Score on a scale Standard Deviation 2.27	0.02 Score on a scale Standard Deviation 2.47
Change in CoEQ: Scores From the 4 Domains and the 19 Items 6) Feeling of anxiousness (wk 26)	0.02 Score on a scale Standard Deviation 2.86	-0.18 Score on a scale Standard Deviation 2.96	0.20 Score on a scale Standard Deviation 3.22	-0.21 Score on a scale Standard Deviation 2.96
Change in CoEQ: Scores From the 4 Domains and the 19 Items 6) Feeling of anxiousness (wk 52)	-0.05 Score on a scale Standard Deviation 2.59	-0.16 Score on a scale Standard Deviation 2.97	-0.06 Score on a scale Standard Deviation 3.02	0.17 Score on a scale Standard Deviation 3.14
Change in CoEQ: Scores From the 4 Domains and the 19 Items 6) Feeling of anxiousness (wk 78)	0.05 Score on a scale Standard Deviation 2.69	0.12 Score on a scale Standard Deviation 3.22	-0.12 Score on a scale Standard Deviation 2.88	-0.01 Score on a scale Standard Deviation 3.21
Change in CoEQ: Scores From the 4 Domains and the 19 Items 7) Feeling of alertness (wk 26)	0.11 Score on a scale Standard Deviation 2.44	0.03 Score on a scale Standard Deviation 2.61	-0.06 Score on a scale Standard Deviation 2.49	0.05 Score on a scale Standard Deviation 2.51
Change in CoEQ: Scores From the 4 Domains and the 19 Items 7) Feeling of alertness (wk 52)	0.01 Score on a scale Standard Deviation 2.52	-0.14 Score on a scale Standard Deviation 2.87	-0.05 Score on a scale Standard Deviation 2.50	-0.05 Score on a scale Standard Deviation 2.56
Change in CoEQ: Scores From the 4 Domains and the 19 Items 7) Feeling of alertness (wk 78)	0.10 Score on a scale Standard Deviation 2.43	-0.04 Score on a scale Standard Deviation 2.69	0.04 Score on a scale Standard Deviation 2.48	-0.01 Score on a scale Standard Deviation 2.64
Change in CoEQ: Scores From the 4 Domains and the 19 Items 8) Feeling of contentment (wk 26)	0.05 Score on a scale Standard Deviation 2.37	0.04 Score on a scale Standard Deviation 2.38	0.18 Score on a scale Standard Deviation 2.37	0.18 Score on a scale Standard Deviation 2.14
Change in CoEQ: Scores From the 4 Domains and the 19 Items 8) Feeling of contentment (wk 52)	0.04 Score on a scale Standard Deviation 2.35	0.08 Score on a scale Standard Deviation 2.48	0.13 Score on a scale Standard Deviation 2.40	0.20 Score on a scale Standard Deviation 2.29
Change in CoEQ: Scores From the 4 Domains and the 19 Items 8) Feeling of contentment (wk 78)	-0.04 Score on a scale Standard Deviation 2.50	-0.03 Score on a scale Standard Deviation 2.41	0.17 Score on a scale Standard Deviation 2.38	0.17 Score on a scale Standard Deviation 2.39
Change in CoEQ: Scores From the 4 Domains and the 19 Items 9) Food cravings during last 7 days (wk 26)	-0.59 Score on a scale Standard Deviation 2.87	-0.41 Score on a scale Standard Deviation 2.94	-0.37 Score on a scale Standard Deviation 2.69	-0.46 Score on a scale Standard Deviation 2.85
Change in CoEQ: Scores From the 4 Domains and the 19 Items 9) Food cravings during last 7 days (wk 52)	-0.40 Score on a scale Standard Deviation 2.99	-0.30 Score on a scale Standard Deviation 2.96	-0.25 Score on a scale Standard Deviation 2.86	-0.21 Score on a scale Standard Deviation 3.09
Change in CoEQ: Scores From the 4 Domains and the 19 Items 9) Food cravings during last 7 days (wk 78)	-0.47 Score on a scale Standard Deviation 2.87	-0.28 Score on a scale Standard Deviation 2.90	-0.38 Score on a scale Standard Deviation 2.91	-0.33 Score on a scale Standard Deviation 3.05
Change in CoEQ: Scores From the 4 Domains and the 19 Items 10) Strength of food cravings (wk 26)	-0.50 Score on a scale Standard Deviation 2.75	-0.33 Score on a scale Standard Deviation 2.93	-0.25 Score on a scale Standard Deviation 2.79	-0.35 Score on a scale Standard Deviation 2.77
Change in CoEQ: Scores From the 4 Domains and the 19 Items 10) Strength of food cravings (wk 52)	-0.23 Score on a scale Standard Deviation 2.84	-0.14 Score on a scale Standard Deviation 2.90	-0.21 Score on a scale Standard Deviation 2.74	-0.30 Score on a scale Standard Deviation 2.77
Change in CoEQ: Scores From the 4 Domains and the 19 Items 10) Strength of food cravings (wk 78)	-0.20 Score on a scale Standard Deviation 2.89	-0.28 Score on a scale Standard Deviation 2.99	-0.32 Score on a scale Standard Deviation 2.85	-0.38 Score on a scale Standard Deviation 2.79
Change in CoEQ: Scores From the 4 Domains and the 19 Items 11) Difficulty to resist food cravings (wk 26)	-0.46 Score on a scale Standard Deviation 2.74	-0.38 Score on a scale Standard Deviation 3.02	-0.46 Score on a scale Standard Deviation 3.04	-0.17 Score on a scale Standard Deviation 2.84
Change in CoEQ: Scores From the 4 Domains and the 19 Items 11) Difficulty to resist food cravings (wk 52)	0.00 Score on a scale Standard Deviation 2.79	-0.23 Score on a scale Standard Deviation 3.04	-0.42 Score on a scale Standard Deviation 3.16	-0.26 Score on a scale Standard Deviation 3.04
Change in CoEQ: Scores From the 4 Domains and the 19 Items 11) Difficulty to resist food cravings (wk 78)	-0.04 Score on a scale Standard Deviation 3.02	-0.32 Score on a scale Standard Deviation 3.20	-0.24 Score on a scale Standard Deviation 3.14	-0.22 Score on a scale Standard Deviation 2.96
Change in CoEQ: Scores From the 4 Domains and the 19 Items 12) Eating in response to food cravings (wk 26)	-0.40 Score on a scale Standard Deviation 2.49	-0.15 Score on a scale Standard Deviation 2.78	-0.17 Score on a scale Standard Deviation 2.78	-0.27 Score on a scale Standard Deviation 2.64
Change in CoEQ: Scores From the 4 Domains and the 19 Items 12) Eating in response to food cravings (wk 52)	-0.04 Score on a scale Standard Deviation 2.55	-0.11 Score on a scale Standard Deviation 2.85	-0.25 Score on a scale Standard Deviation 2.73	-0.17 Score on a scale Standard Deviation 2.75
Change in CoEQ: Scores From the 4 Domains and the 19 Items 12) Eating in response to food cravings (wk 78)	-0.02 Score on a scale Standard Deviation 2.67	0.01 Score on a scale Standard Deviation 2.76	-0.17 Score on a scale Standard Deviation 2.96	-0.25 Score on a scale Standard Deviation 2.73
Change in CoEQ: Scores From the 4 Domains and the 19 Items 13) Cravings for chocolate (wk 26)	-0.27 Score on a scale Standard Deviation 2.69	-0.03 Score on a scale Standard Deviation 2.93	-0.14 Score on a scale Standard Deviation 2.94	-0.15 Score on a scale Standard Deviation 2.78
Change in CoEQ: Scores From the 4 Domains and the 19 Items 13) Cravings for chocolate (wk 52)	-0.28 Score on a scale Standard Deviation 2.58	0.03 Score on a scale Standard Deviation 2.93	0.06 Score on a scale Standard Deviation 2.87	0.03 Score on a scale Standard Deviation 2.85
Change in CoEQ: Scores From the 4 Domains and the 19 Items 13) Cravings for chocolate (wk 78)	-0.08 Score on a scale Standard Deviation 2.74	0.00 Score on a scale Standard Deviation 2.87	0.06 Score on a scale Standard Deviation 3.01	0.06 Score on a scale Standard Deviation 3.04
Change in CoEQ: Scores From the 4 Domains and the 19 Items 14) Cravings for other sweet foods (wk 26)	-0.33 Score on a scale Standard Deviation 2.65	-0.31 Score on a scale Standard Deviation 2.91	-0.36 Score on a scale Standard Deviation 2.82	-0.33 Score on a scale Standard Deviation 2.82
Change in CoEQ: Scores From the 4 Domains and the 19 Items 14) Cravings for other sweet foods (wk 52)	-0.33 Score on a scale Standard Deviation 2.79	-0.34 Score on a scale Standard Deviation 2.93	-0.31 Score on a scale Standard Deviation 2.96	-0.09 Score on a scale Standard Deviation 2.90
Change in CoEQ: Scores From the 4 Domains and the 19 Items 14) Cravings for other sweet foods (wk 78)	-0.20 Score on a scale Standard Deviation 2.84	-0.14 Score on a scale Standard Deviation 3.01	-0.40 Score on a scale Standard Deviation 2.93	-0.22 Score on a scale Standard Deviation 2.87
Change in CoEQ: Scores From the 4 Domains and the 19 Items 15) Cravings for fruit or fruit juice (wk 26)	-0.20 Score on a scale Standard Deviation 3.05	-0.03 Score on a scale Standard Deviation 3.27	-0.09 Score on a scale Standard Deviation 3.04	-0.07 Score on a scale Standard Deviation 3.09
Change in CoEQ: Scores From the 4 Domains and the 19 Items 15) Cravings for fruit or fruit juice (wk 52)	-0.40 Score on a scale Standard Deviation 2.99	-0.01 Score on a scale Standard Deviation 3.34	-0.22 Score on a scale Standard Deviation 3.07	-0.08 Score on a scale Standard Deviation 3.02
Change in CoEQ: Scores From the 4 Domains and the 19 Items 15) Cravings for fruit or fruit juice (wk 78)	-0.14 Score on a scale Standard Deviation 2.97	-0.11 Score on a scale Standard Deviation 3.51	-0.02 Score on a scale Standard Deviation 3.12	-0.33 Score on a scale Standard Deviation 2.88
Change in CoEQ: Scores From the 4 Domains and the 19 Items 16) Cravings for dairy foods (wk 26)	-0.23 Score on a scale Standard Deviation 3.06	-0.20 Score on a scale Standard Deviation 2.90	-0.37 Score on a scale Standard Deviation 3.02	-0.27 Score on a scale Standard Deviation 2.83
Change in CoEQ: Scores From the 4 Domains and the 19 Items 16) Cravings for dairy foods (wk 52)	-0.42 Score on a scale Standard Deviation 2.96	-0.30 Score on a scale Standard Deviation 2.97	-0.41 Score on a scale Standard Deviation 2.86	0.04 Score on a scale Standard Deviation 2.89
Change in CoEQ: Scores From the 4 Domains and the 19 Items 16) Cravings for dairy foods (wk 78)	-0.30 Score on a scale Standard Deviation 3.00	-0.20 Score on a scale Standard Deviation 2.95	-0.45 Score on a scale Standard Deviation 2.86	-0.20 Score on a scale Standard Deviation 2.81
Change in CoEQ: Scores From the 4 Domains and the 19 Items 17) Cravings for starchy foods (wk 26)	-0.42 Score on a scale Standard Deviation 2.65	-0.24 Score on a scale Standard Deviation 2.56	-0.49 Score on a scale Standard Deviation 2.75	-0.42 Score on a scale Standard Deviation 2.86
Change in CoEQ: Scores From the 4 Domains and the 19 Items 17) Cravings for starchy foods (wk 52)	-0.54 Score on a scale Standard Deviation 2.86	-0.35 Score on a scale Standard Deviation 2.68	-0.62 Score on a scale Standard Deviation 2.80	-0.28 Score on a scale Standard Deviation 2.68
Change in CoEQ: Scores From the 4 Domains and the 19 Items 17) Cravings for starchy foods (wk 78)	-0.44 Score on a scale Standard Deviation 2.94	-0.32 Score on a scale Standard Deviation 2.76	-0.61 Score on a scale Standard Deviation 2.86	-0.36 Score on a scale Standard Deviation 2.72
Change in CoEQ: Scores From the 4 Domains and the 19 Items 18) Cravings for savoury foods (wk 26)	-0.41 Score on a scale Standard Deviation 2.74	-0.16 Score on a scale Standard Deviation 2.69	-0.49 Score on a scale Standard Deviation 2.85	-0.40 Score on a scale Standard Deviation 2.70
Change in CoEQ: Scores From the 4 Domains and the 19 Items 18) Cravings for savoury foods (wk 52)	-0.41 Score on a scale Standard Deviation 2.85	-0.20 Score on a scale Standard Deviation 2.82	-0.56 Score on a scale Standard Deviation 2.72	-0.37 Score on a scale Standard Deviation 2.73
Change in CoEQ: Scores From the 4 Domains and the 19 Items 18) Cravings for savoury foods (wk 78)	-0.27 Score on a scale Standard Deviation 2.88	-0.16 Score on a scale Standard Deviation 2.87	-0.48 Score on a scale Standard Deviation 2.95	-0.34 Score on a scale Standard Deviation 2.60
Change in CoEQ: Scores From the 4 Domains and the 19 Items 19) Difficulty to control eating in general(wk 26)	-0.47 Score on a scale Standard Deviation 2.68	-0.69 Score on a scale Standard Deviation 2.77	-0.49 Score on a scale Standard Deviation 2.69	-0.51 Score on a scale Standard Deviation 2.70
Change in CoEQ: Scores From the 4 Domains and the 19 Items 19) Difficulty to control eating in general(wk 52)	-0.32 Score on a scale Standard Deviation 2.76	-0.59 Score on a scale Standard Deviation 2.86	-0.56 Score on a scale Standard Deviation 2.75	-0.51 Score on a scale Standard Deviation 2.73
Change in CoEQ: Scores From the 4 Domains and the 19 Items 19) Difficulty to control eating in general(wk 78)	-0.40 Score on a scale Standard Deviation 2.71	-0.59 Score on a scale Standard Deviation 2.88	-0.54 Score on a scale Standard Deviation 2.71	-0.51 Score on a scale Standard Deviation 2.81
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving control: items 9-12, 19 (wk 26)	0.49 Score on a scale Standard Deviation 2.13	0.39 Score on a scale Standard Deviation 2.18	0.35 Score on a scale Standard Deviation 2.16	0.35 Score on a scale Standard Deviation 2.10
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving control: items 9-12, 19 (wk 52)	0.20 Score on a scale Standard Deviation 2.20	0.27 Score on a scale Standard Deviation 2.26	0.34 Score on a scale Standard Deviation 2.21	0.29 Score on a scale Standard Deviation 2.18
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving control: items 9-12, 19 (wk 78)	0.22 Score on a scale Standard Deviation 2.30	0.29 Score on a scale Standard Deviation 2.35	0.33 Score on a scale Standard Deviation 2.29	0.34 Score on a scale Standard Deviation 2.19
Change in CoEQ: Scores From the 4 Domains and the 19 Items Positive mood: items 5-8 (wk 26)	0.04 Score on a scale Standard Deviation 1.51	0.07 Score on a scale Standard Deviation 1.43	-0.01 Score on a scale Standard Deviation 1.61	0.15 Score on a scale Standard Deviation 1.47
Change in CoEQ: Scores From the 4 Domains and the 19 Items Positive mood: items 5-8 (wk 52)	0.04 Score on a scale Standard Deviation 1.50	0.03 Score on a scale Standard Deviation 1.54	0.05 Score on a scale Standard Deviation 1.60	0.03 Score on a scale Standard Deviation 1.57
Change in CoEQ: Scores From the 4 Domains and the 19 Items Positive mood: items 5-8 (wk 78)	-0.01 Score on a scale Standard Deviation 1.57	-0.07 Score on a scale Standard Deviation 1.52	0.09 Score on a scale Standard Deviation 1.55	0.05 Score on a scale Standard Deviation 1.74
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving for savoury: items 4, 16-18 (wk 26)	-0.33 Score on a scale Standard Deviation 1.88	-0.19 Score on a scale Standard Deviation 1.94	-0.41 Score on a scale Standard Deviation 2.07	-0.36 Score on a scale Standard Deviation 1.89
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving for savoury: items 4, 16-18 (wk 52)	-0.41 Score on a scale Standard Deviation 2.01	-0.27 Score on a scale Standard Deviation 1.95	-0.51 Score on a scale Standard Deviation 2.11	-0.24 Score on a scale Standard Deviation 1.88
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving for savoury: items 4, 16-18 (wk 78)	-0.35 Score on a scale Standard Deviation 2.06	-0.26 Score on a scale Standard Deviation 2.12	-0.48 Score on a scale Standard Deviation 2.08	-0.33 Score on a scale Standard Deviation 1.93
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving for sweet: items 3, 13-15 (wk 26)	-0.30 Score on a scale Standard Deviation 1.88	-0.23 Score on a scale Standard Deviation 2.12	-0.26 Score on a scale Standard Deviation 2.10	-0.22 Score on a scale Standard Deviation 2.01
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving for sweet: items 3, 13-15 (wk 52)	-0.33 Score on a scale Standard Deviation 1.97	-0.15 Score on a scale Standard Deviation 2.17	-0.19 Score on a scale Standard Deviation 2.19	-0.15 Score on a scale Standard Deviation 2.06
Change in CoEQ: Scores From the 4 Domains and the 19 Items Craving for sweet: items 3, 13-15 (wk 78)	-0.20 Score on a scale Standard Deviation 1.94	-0.16 Score on a scale Standard Deviation 2.22	-0.20 Score on a scale Standard Deviation 2.20	-0.24 Score on a scale Standard Deviation 2.06

Adverse Events

Oral Semaglutide 3 mg

Serious events: 64 serious events

Other events: 222 other events

Deaths: 5 deaths

Oral Semaglutide 7 mg

Serious events: 47 serious events

Other events: 234 other events

Deaths: 4 deaths

Oral Semaglutide 14 mg

Serious events: 44 serious events

Other events: 232 other events

Deaths: 1 deaths

Sitagliptin 100 mg

Serious events: 58 serious events

Other events: 239 other events

Deaths: 3 deaths

Serious adverse events

Measure	Oral Semaglutide 3 mg n=466 participants at risk Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 participants at risk Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Gastrointestinal disorders Abdominal pain	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Abdominal wall abscess	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Acute coronary syndrome	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.65% 3/465 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Acute left ventricular failure	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Acute myocardial infarction	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 respiratory distress syndrome	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 respiratory failure	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Blood and lymphatic system disorders Anaemia	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 pectoris	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.65% 3/464 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Angioedema	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Appendicitis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Ascites	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Asthma	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/464 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.86% 4/466 • Number of events 4 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 flutter	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) B-cell lymphoma	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Barrett's oesophagus	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Bile duct stone	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Brain neoplasm malignant	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Brain stem stroke	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Breast cancer	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Breast cancer metastatic	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 arrest	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 acute	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cardio-respiratory arrest	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 diabetic	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cellulitis	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cervical vertebral fracture	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cervicobrachial syndrome	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 chronic	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cholecystitis infective	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cholelithiasis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Chronic hepatic failure	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Chronic obstructive pulmonary disease	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Cirrhosis alcoholic	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Clavicle fracture	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Colon cancer	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Complication associated with device	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Congestive cardiomyopathy	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Conjunctival irritation	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/464 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 stenosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Deafness neurosensory	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Deep vein thrombosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Product Issues Device dislocation	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Diabetes mellitus inadequate control	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Diabetic amyotrophy	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Diabetic metabolic decompensation	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Diabetic retinopathy	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Encephalopathy	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 End stage renal disease	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Endometrial hyperplasia	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Epistaxis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Essential hypertension	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Exostosis of external ear canal	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Facial paralysis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Faeces discoloured	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Fatigue	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Focal dyscognitive seizures	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Gastritis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Endocrine disorders Goitre	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Haematuria	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Haemorrhage intracranial	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Haemorrhagic stroke	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hepatic cirrhosis	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hepatitis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hospitalisation	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hypertension	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hypertensive heart disease	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hypoglycaemia	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Endocrine disorders Hypopituitarism	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hypotension	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Incisional hernia	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Incisional hernia, obstructive	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Intervertebral disc protrusion	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Blood and lymphatic system disorders Iron deficiency anaemia	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Laparoscopic surgery	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Large intestine polyp	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Liver function test abnormal	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Lumbar spinal stenosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Mallory-Weiss syndrome	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 fibrosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 infarction	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Nasal cavity cancer	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Neck pain	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Nephrolithiasis	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Neuropathy peripheral	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Neurosyphilis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Non-alcoholic steatohepatitis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Oedema peripheral	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/464 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.65% 3/465 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Osteochondrosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Osteomyelitis	0.21% 1/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 cancer metastatic	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Pancreatic carcinoma metastatic	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Pancreatic cyst	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Pancreatic neuroendocrine tumour	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Pancreatitis acute	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.65% 3/465 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Pelvic abscess	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 arterial occlusive disease	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 occlusion	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Peritonitis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Peritonitis bacterial	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Plasma cell myeloma	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Pneumonia	0.64% 3/466 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.86% 4/466 • Number of events 4 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Pneumonia klebsiella	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Polyp	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Prostatic specific antigen increased	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Prostatitis	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 acute	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Rectal adenocarcinoma	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Renal cell carcinoma	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 cyst	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Retinal detachment	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Retinal haemorrhage	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Retinopathy proliferative	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Rotator cuff syndrome	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Immune system disorders Sarcoidosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Scapula fracture	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Sciatica	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Sepsis	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Septic phlebitis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Skull fractured base	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Sleep apnoea syndrome	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Soft tissue injury	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Spinal osteoarthritis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Subarachnoid haemorrhage	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Subcutaneous abscess	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/464 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Subdural haematoma	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.43% 2/464 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Supraventricular tachycardia	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Syncope	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 3 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Synovitis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Testicular abscess	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Thalamic infarction	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Thrombosis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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) Thyroid cancer	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Transient ischaemic attack	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Ulna fracture	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Umbilical hernia repair	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Upper limb fracture	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Urinary tract infection	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Urosepsis	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.43% 2/466 • Number of events 2 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Uterine polyp	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Uterine prolapse	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Varicose vein	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Vascular pseudoaneurysm	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Vertigo	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Vestibular neuronitis	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Viral infection	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/465 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	0.00% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	0.22% 1/464 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Wound infection staphylococcal	0.21% 1/466 • Number of events 1 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/464 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/465 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a 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% 0/466 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 3 mg n=466 participants at risk Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 7 mg n=464 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Oral Semaglutide 14 mg n=465 participants at risk Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78.	Sitagliptin 100 mg n=466 participants at risk Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78.
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 21/466 • Number of events 29 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 13/464 • Number of events 17 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 20/465 • Number of events 25 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.2% 29/466 • Number of events 32 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	5.2% 24/466 • Number of events 35 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.4% 25/464 • Number of events 31 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 24/465 • Number of events 25 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.2% 29/466 • Number of events 35 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Decreased appetite	1.7% 8/466 • Number of events 8 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 14/464 • Number of events 15 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.9% 32/465 • Number of events 32 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 14/466 • Number of events 15 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Diabetic retinopathy	5.8% 27/466 • Number of events 27 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 24/464 • Number of events 25 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.4% 16/465 • Number of events 16 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.6% 26/466 • Number of events 27 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	9.4% 44/466 • Number of events 62 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	11.4% 53/464 • Number of events 81 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	12.0% 56/465 • Number of events 74 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 37/466 • Number of events 44 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	6.2% 29/466 • Number of events 37 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.5% 30/464 • Number of events 40 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.7% 36/465 • Number of events 50 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.7% 36/466 • Number of events 57 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Hypertension	6.2% 29/466 • Number of events 32 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 24/464 • Number of events 27 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.6% 26/465 • Number of events 26 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.2% 29/466 • Number of events 29 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	6.2% 29/466 • Number of events 35 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 24/464 • Number of events 28 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	3.9% 18/465 • Number of events 21 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.4% 30/466 • Number of events 35 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	11.4% 53/466 • Number of events 74 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	10.6% 49/464 • Number of events 65 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	10.1% 47/465 • Number of events 57 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	10.1% 47/466 • Number of events 69 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	7.3% 34/466 • Number of events 42 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 62/464 • Number of events 74 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	15.1% 70/465 • Number of events 88 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 31/466 • Number of events 39 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	7.7% 36/466 • Number of events 53 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	7.5% 35/464 • Number of events 50 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.6% 26/465 • Number of events 34 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	6.9% 32/466 • Number of events 49 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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 Urinary tract infection	6.2% 29/466 • Number of events 32 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.5% 21/464 • Number of events 26 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	4.9% 23/465 • Number of events 30 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.6% 26/466 • Number of events 32 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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	2.8% 13/466 • Number of events 15 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	5.8% 27/464 • Number of events 41 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.	9.0% 42/465 • Number of events 82 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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% 19/466 • Number of events 26 • Week 0 to week 83 (78 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product. Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when 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.
• Publication restrictions are in place

Restriction type: OTHER