Trial Outcomes & Findings for A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02164513)

NCT ID: NCT02164513

Last Updated: 2018-10-10

Results Overview

The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

10355 participants

Primary outcome timeframe

Up to Week 52

Results posted on

2018-10-10

Participant Flow

Participants with chronic obstructive pulmonary disease (COPD), were randomized to the study. Study was conducted from 30 June 2014 to 17 July 2017, at total of 971 sites in 37 countries.

Participant milestones

Participant milestones
Measure	FF/UMEC/VI The eligible participants in this arm received Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) as a fixed dose combination (FDC) as 100 microgram (µcg)/62.5µcg/25µcg once daily (QD) via a dry powder inhaler (DPI), in the morning, for duration of 52 weeks.	FF/VI The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Overall Study STARTED	4151	4134	2070
Overall Study Completed Investigational Product (IP)	3393	3094	1504
Overall Study Not Completed IP	758	1040	566
Overall Study Withdrew IP (WIP): Adverse Event	249	325	186
Overall Study WIP: Lack of Efficacy	163	313	172
Overall Study Withdrew IP: Protocol Deviation	32	41	19
Overall Study WIP (Other): Stopping Criteria Reached	4	1	2
Overall Study WIP: Study Closed/Terminated	5	2	5
Overall Study WIP: Lost to Follow-up	21	25	14
Overall Study WIP: Investigator Discretion	33	36	15
Overall Study WIP: Withdrawal by Participant	250	296	153
Overall Study WIP :Did Not Complete Study Treatment	1	1	0
Overall Study COMPLETED	3714	3598	1775
Overall Study NOT COMPLETED	437	536	295

Reasons for withdrawal

Reasons for withdrawal
Measure	FF/UMEC/VI The eligible participants in this arm received Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) as a fixed dose combination (FDC) as 100 microgram (µcg)/62.5µcg/25µcg once daily (QD) via a dry powder inhaler (DPI), in the morning, for duration of 52 weeks.	FF/VI The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Overall Study Adverse Event	162	180	111
Overall Study Other: Study Closed or terminated	5	2	4
Overall Study Lost to Follow-up	30	36	22
Overall Study Physician Decision	47	57	28
Overall Study Withdrawal by Subject	192	261	130
Overall Study Other: Reason not provided by site	1	0	0

Baseline Characteristics

A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FF/UMEC/VI n=4151 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=4134 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI n=2070 Participants The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	Total n=10355 Participants Total of all reporting groups
Age, Continuous	65.3 Years STANDARD_DEVIATION 8.24 • n=5 Participants	65.3 Years STANDARD_DEVIATION 8.30 • n=7 Participants	65.2 Years STANDARD_DEVIATION 8.26 • n=5 Participants	65.3 Years STANDARD_DEVIATION 8.27 • n=4 Participants
Sex: Female, Male Female	1385 Participants n=5 Participants	1386 Participants n=7 Participants	714 Participants n=5 Participants	3485 Participants n=4 Participants
Sex: Female, Male Male	2766 Participants n=5 Participants	2748 Participants n=7 Participants	1356 Participants n=5 Participants	6870 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	87 Participants n=5 Participants	86 Participants n=7 Participants	45 Participants n=5 Participants	218 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	6 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	362 Participants n=5 Participants	374 Participants n=7 Participants	177 Participants n=5 Participants	913 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	151 Participants n=5 Participants	152 Participants n=7 Participants	82 Participants n=5 Participants	385 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	149 Participants n=5 Participants	147 Participants n=7 Participants	75 Participants n=5 Participants	371 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	122 Participants n=5 Participants	99 Participants n=7 Participants	43 Participants n=5 Participants	264 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	31 Participants n=5 Participants	45 Participants n=7 Participants	24 Participants n=5 Participants	100 Participants n=4 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	3200 Participants n=5 Participants	3179 Participants n=7 Participants	1604 Participants n=5 Participants	7983 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	41 Participants n=5 Participants	45 Participants n=7 Participants	17 Participants n=5 Participants	103 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to Week 52

Population: ITT Population.

The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=4145 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=4133 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI n=2069 Participants The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI	0.91 Exacerbations per participant per year Interval 0.87 to 0.95	1.07 Exacerbations per participant per year Interval 1.02 to 1.12	1.21 Exacerbations per participant per year Interval 1.14 to 1.29

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: ITT Population.

FEV1 was defined as the amount of air a person exhales in one second. Change from Baseline was calculated as the value of FEV1 at Week 52 minus the value at Baseline. Baseline for trough FEV1 was defined as Day 1 (Pre-dose). Only those participants with non-missing co-variates were included in the analysis. The analysis was performed using a Repeated measures model with covariates of treatment group, smoking status (Screening), geographical region, visit, Baseline, Baseline by visit and treatment group by visit interactions.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=3366 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=3060 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI	0.094 Liter Standard Error 0.0042	-0.003 Liter Standard Error 0.0044	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: ITT Population.

SGRQ is a disease specific-questionnaire, designed to measure impact of respiratory disease and its treatment on a COPD participant's Health Related Quality of Life (HRQoL). SGRQ contains 14 questions with total of 40 items grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score along with scores for the individual domains of symptoms, activity and impacts were assessed. Score was calculated by summing the pre-assigned weights of answers, dividing by sum of maximum weights for items in SGRQ. Total scores ranged from 0 to 100. A decrease in score indicates improvement in HRQoL and higher score implies worse quality of life. Change from Baseline was calculated as total score at Week 52 minus value at Baseline. Baseline was defined as Day 1. Minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Only those participants with non-missing co-variates were included in the analysis.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=3318 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=3026 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI	-5.5 Scores on SGRQ scale Standard Error 0.23	-3.7 Scores on SGRQ scale Standard Error 0.24	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT Population.

This measures the number of days, to the first onset of moderate or severe exacerbations. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. The Hazard ratio from Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening), have been reported. Only those participants with non-missing co-variates were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=1959 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=2039 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI n=1036 Participants The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI First quartile time to onset	112 Days	81 Days	73 Days
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI Median time to onset	NA Days If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.	NA Days If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.	306 Days

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT Population

The annual rate of moderate or severe COPD exacerbations during the treatment, for participants with blood eosinophil count \>=150 cells per microliter , has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non-missing eosinophil, at Baseline were included in the analysis.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=2296 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=1195 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter	0.95 Exacerbations per participant per year Interval 0.9 to 1.01	1.39 Exacerbations per participant per year Interval 1.29 to 1.51	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT Population

This measures the number of days, to the first onset of moderate or severe exacerbations for participants with blood eosinophil count \>=150 cells per microliter, at Baseline has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non missing eosinophils at Baseline were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=2296 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=1195 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline First quartile time to onset	107 Days	55 Days	—
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline Median time to onset	NA Days If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.	253 Days	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: ITT Population.

The annual rate of severe COPD exacerbations during the treatment, has been reported. Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. The covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening) were used. Only those participants with non-missing co-variates were included in the analysis

Outcome measures

Outcome measures
Measure	FF/UMEC/VI n=4145 Participants The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI n=4133 Participants The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI n=2069 Participants The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI	0.13 Exacerbations per participant per year Interval 0.12 to 0.14	0.15 Exacerbations per participant per year Interval 0.13 to 0.16	0.19 Exacerbations per participant per year Interval 0.17 to 0.22

Adverse Events

FF/UMEC/VI 100/62.5/25

Serious events: 895 serious events

Other events: 1389 other events

Deaths: 68 deaths

FF/VI 100/25

Serious events: 850 serious events

Other events: 1278 other events

Deaths: 76 deaths

UMEC/VI 62.5/25

Serious events: 470 serious events

Other events: 596 other events

Deaths: 49 deaths

Serious adverse events

Serious adverse events
Measure	FF/UMEC/VI 100/62.5/25 n=4151 participants at risk The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI 100/25 n=4134 participants at risk The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI 62.5/25 n=2070 participants at risk The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Gastrointestinal disorders Abdominal pain upper	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Anaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Leukocytosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Microcytic anaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Acute coronary syndrome	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Acute left ventricular failure	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Acute myocardial infarction	0.31% 13/4151 • Number of events 14 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.19% 8/4134 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.29% 6/2070 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Angina pectoris	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Angina unstable	0.17% 7/4151 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.15% 6/4134 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Aortic valve incompetence	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Aortic valve stenosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrial fibrillation	0.51% 21/4151 • Number of events 24 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.31% 13/4134 • Number of events 13 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.29% 6/2070 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrial flutter	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrial tachycardia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrial thrombosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrioventricular block	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrioventricular block complete	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Atrioventricular dissociation	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Bradycardia	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac arrest	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac failure	0.29% 12/4151 • Number of events 12 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.17% 7/4134 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac failure acute	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac failure chronic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac failure congestive	0.51% 21/4151 • Number of events 28 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.29% 12/4134 • Number of events 12 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.34% 7/2070 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiac valve disease	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardio-respiratory arrest	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.24% 5/2070 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiogenic shock	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiomyopathy	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cardiopulmonary failure	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cor pulmonale	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Cor pulmonale chronic	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Coronary artery disease	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Coronary artery insufficiency	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Coronary artery occlusion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Coronary artery stenosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Ischaemic cardiomyopathy	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Left ventricular failure	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Mitral valve incompetence	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Myocardial infarction	0.24% 10/4151 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.15% 6/4134 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.34% 7/2070 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Myocardial ischaemia	0.12% 5/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Palpitations	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Pericardial effusion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Prinzmetal angina	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Right ventricular failure	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Sinus arrest	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Sinus node dysfunction	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Supraventricular extrasystoles	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Supraventricular tachycardia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Tachyarrhythmia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Tachycardia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Tricuspid valve incompetence	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Ventricular arrhythmia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Ventricular extrasystoles	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Ventricular fibrillation	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Cardiac disorders Ventricular tachycardia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Congenital, familial and genetic disorders Myocardial bridging	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Congenital, familial and genetic disorders Odontogenic cyst	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Ear and labyrinth disorders Meniere's disease	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Ear and labyrinth disorders Vertigo	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Endocrine disorders Adrenal mass	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Endocrine disorders Hyperthyroidism	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Amaurosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Cataract	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Cataract nuclear	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Conjunctival haemorrhage	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Diplopia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Retinal detachment	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Eye disorders Vitreous haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal discomfort	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal distension	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal hernia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal pain	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Anal fistula	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Ascites	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Colitis	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Colitis ulcerative	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Constipation	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Crohn's disease	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Diarrhoea	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Duodenitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Dysphagia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Erosive duodenitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Erosive oesophagitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Faecaloma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastric polyps	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastric ulcer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastritis	0.10% 4/4151 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastritis erosive	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Haematemesis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Haemorrhoids	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Ileus	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Inguinal hernia	0.14% 6/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Intestinal obstruction	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Intestinal perforation	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Intestinal polyp	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Irritable bowel syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Large intestine polyp	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Nausea	0.02% 1/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Pancreatic failure	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Pancreatitis	0.07% 3/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Pancreatitis acute	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Retroperitoneal fibrosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Umbilical hernia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Gastrointestinal disorders Vomiting	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Asthenia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Chest discomfort	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Chest pain	0.12% 5/4151 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.34% 7/2070 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Complication associated with device	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Condition aggravated	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Death	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders General physical health deterioration	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Hernia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Impaired healing	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Implant site fibrosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Incarcerated hernia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Medical device site haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Multiple organ dysfunction syndrome	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Non-cardiac chest pain	0.19% 8/4151 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.24% 10/4134 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Oedema peripheral	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Pain	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Peripheral swelling	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Pyrexia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Stent-graft endoleak	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Sudden cardiac death	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Sudden death	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
General disorders Systemic inflammatory response syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Biliary colic	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Cholecystitis	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Cholecystitis acute	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Cholelithiasis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.24% 5/2070 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Gallbladder perforation	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Gallbladder polyp	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Hepatobiliary disorders Hepatitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Immune system disorders Allergy to arthropod sting	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Immune system disorders Anaphylactic reaction	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Immune system disorders Anaphylactic shock	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Immune system disorders Drug hypersensitivity	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Abdominal abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Acute sinusitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Anal abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Appendiceal abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Appendicitis	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Appendicitis perforated	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Arthritis bacterial	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Aspergillus infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Bacterial sepsis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Bronchiolitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Bronchitis	0.24% 10/4151 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.24% 10/4134 • Number of events 11 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Bronchitis bacterial	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Carbuncle	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Cellulitis	0.14% 6/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Cellulitis staphylococcal	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Cholecystitis infective	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Clostridial infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Clostridium difficile colitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Clostridium difficile infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Colonic abscess	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Corona virus infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Cystitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Device related infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Diarrhoea infectious	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Diverticulitis	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Empyema	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Endocarditis bacterial	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Enteritis infectious	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Enterocolitis infectious	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Erysipelas	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Escherichia urinary tract infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Fungal oesophagitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Gangrene	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Gastroenteritis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Gastroenteritis salmonella	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Gastroenteritis viral	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations H1N1 influenza	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Haemophilus infection	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Helicobacter gastritis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Helicobacter infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Hepatitis C	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Herpes zoster	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infected skin ulcer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infected varicose vein	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infectious colitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infectious pleural effusion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infective exacerbation of bronchiectasis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.19% 8/4151 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.46% 19/4134 • Number of events 20 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.34% 7/2070 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Influenza	0.17% 7/4151 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.15% 6/4134 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.24% 5/2070 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Kidney infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Laryngitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Liver abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Lower respiratory tract infection	0.17% 7/4151 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.19% 4/2070 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Lung abscess	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Lung infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Meningitis viral	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Mycobacterial infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Mycoplasma infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Nosocomial infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Oesophageal candidiasis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Oral infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Orchitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Osteomyelitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Osteomyelitis acute	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Parainfluenzae virus infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Parotitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Peritonitis	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pharyngotonsillitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumococcal sepsis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia	4.4% 184/4151 • Number of events 198 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	3.7% 152/4134 • Number of events 165 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	2.6% 54/2070 • Number of events 55 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia bacterial	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.22% 9/4134 • Number of events 9 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia fungal	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia haemophilus	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia influenzal	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia klebsiella	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia necrotising	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia pneumococcal	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia pseudomonal	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia staphylococcal	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Postoperative wound infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pseudomonas infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pulmonary tuberculosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pyelonephritis acute	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Respiratory syncytial virus infection	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Respiratory tract infection	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Respiratory tract infection bacterial	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Respiratory tract infection viral	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Rhinovirus infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Sepsis	0.22% 9/4151 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.19% 8/4134 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.29% 6/2070 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Sepsis syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Septic shock	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Sinusitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Soft tissue infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Staphylococcal infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Streptococcal infection	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Subacute endocarditis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Subcutaneous abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Superinfection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Tonsillitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Tooth abscess	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Tracheobronchitis	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Tuberculosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Upper respiratory tract infection	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Urinary tract infection	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.17% 7/4134 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.19% 4/2070 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Urosepsis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Viral upper respiratory tract infection	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Alcohol poisoning	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Animal bite	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Ankle fracture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Chest injury	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Conjunctival laceration	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Craniocerebral injury	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Femoral neck fracture	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Femur fracture	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Foot fracture	0.07% 3/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Foreign body	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Foreign body aspiration	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Gastrointestinal disorder postoperative	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Hand fracture	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Head injury	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Heat illness	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Hip fracture	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Humerus fracture	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Incisional hernia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Joint injury	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Limb injury	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Lower limb fracture	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Meniscus injury	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Multiple injuries	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Muscle rupture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Overdose	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Pelvic fracture	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Post procedural haematoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Post procedural haematuria	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Post procedural stroke	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Procedural pain	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Radius fracture	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Rib fracture	0.22% 9/4151 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Seroma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Skin injury	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Spinal compression fracture	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Splenic rupture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Stress fracture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Tendon rupture	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Tibia fracture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Toxicity to various agents	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Ulna fracture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Biopsy prostate	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Blood glucose increased	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Blood pressure increased	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations C-reactive protein increased	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Fibrin D dimer increased	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Hepatic enzyme increased	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Occult blood positive	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Prostatic specific antigen increased	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Streptococcus test positive	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Transaminases increased	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Troponin increased	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Investigations Weight decreased	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Acetonaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Dehydration	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Diabetes mellitus	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Fluid overload	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Gout	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hyperlipidaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.17% 7/4151 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.12% 5/4151 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hypophagia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Hypovolaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Lactic acidosis	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Metabolic acidosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Obesity	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Bone infarction	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Bursitis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Costochondritis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Groin pain	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Neck pain	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.22% 9/4151 • Number of events 9 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign fallopian tube neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage I	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage I	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epiglottic carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glottis carcinoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of spleen	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic angiosarcoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage III	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage I	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.14% 6/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.24% 10/4134 • Number of events 10 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage II	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue sarcoma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Aphasia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Ataxia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Brain stem ischaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Brain stem stroke	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Carotid artery occlusion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Carotid artery stenosis	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebellar infarction	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebral amyloid angiopathy	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebral haemorrhage	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebral infarction	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebral ischaemia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebrovascular accident	0.17% 7/4151 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.15% 6/4134 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebrovascular disorder	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cerebrovascular insufficiency	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Cognitive disorder	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Dizziness	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Encephalopathy	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Guillain-Barre syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Haemorrhage intracranial	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Headache	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Hemiparesis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Hypoaesthesia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Intracranial aneurysm	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Ischaemic stroke	0.10% 4/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Lacunar infarction	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Loss of consciousness	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Mental impairment	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Metabolic encephalopathy	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Migraine	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Myoclonus	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Paraesthesia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Parkinson's disease	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Peripheral nerve paresis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Post herpetic neuralgia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Presyncope	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Radicular syndrome	0.02% 1/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Sciatica	0.07% 3/4151 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Seizure	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Simple partial seizures	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Syncope	0.14% 6/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Tension headache	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Thalamic infarction	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Transient ischaemic attack	0.19% 8/4151 • Number of events 8 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Affective disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Alcoholism	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Anxiety	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Completed suicide	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Confusional state	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Delirium	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Depression	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Depression suicidal	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Insomnia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Major depression	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Mental status changes	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Psychotic disorder due to a general medical condition	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Psychiatric disorders Suicide attempt	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Acute kidney injury	0.14% 6/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.22% 9/4134 • Number of events 9 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.29% 6/2070 • Number of events 9 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Bladder disorder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Bladder stenosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Calculus bladder	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Chronic kidney disease	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders End stage renal disease	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Haematuria	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Hydronephrosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Nephropathy	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Obstructive uropathy	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Proteinuria	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Renal aneurysm	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Renal colic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Renal cyst haemorrhage	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Renal failure	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Ureterolithiasis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Urinary incontinence	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Urinary retention	0.05% 2/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Renal and urinary disorders Vesicocutaneous fistula	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Reproductive system and breast disorders Cystocele	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Reproductive system and breast disorders Prostatitis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.55% 23/4151 • Number of events 27 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.41% 17/4134 • Number of events 17 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.77% 16/2070 • Number of events 20 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	10.7% 443/4151 • Number of events 554 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	10.9% 450/4134 • Number of events 569 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	13.0% 269/2070 • Number of events 337 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 4/4134 • Number of events 4 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.19% 8/4151 • Number of events 13 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.27% 11/4134 • Number of events 12 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.14% 3/2070 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.12% 5/4151 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.12% 5/4134 • Number of events 5 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.17% 7/4151 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.17% 7/4134 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.29% 6/2070 • Number of events 6 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary hilum mass	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.53% 22/4151 • Number of events 23 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.51% 21/4134 • Number of events 21 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.34% 7/2070 • Number of events 7 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Diabetic foot	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Peau d'orange	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Psoriasis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Surgical and medical procedures Hernia repair	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Acute aortic syndrome	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Aneurysm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Aortic aneurysm	0.05% 2/4151 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Aortic aneurysm rupture	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Aortic stenosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Arteriosclerosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Circulatory collapse	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Deep vein thrombosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Embolism arterial	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Femoral artery aneurysm	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Haematoma	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Haemodynamic instability	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Haemorrhage	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Hypertension	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.07% 3/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Hypertensive crisis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Hypertensive emergency	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Hypotension	0.07% 3/4151 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 3 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Iliac artery occlusion	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Intermittent claudication	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Ischaemia	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Orthostatic hypotension	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Peripheral arterial occlusive disease	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 2/4134 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Peripheral artery aneurysm	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Peripheral artery occlusion	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.10% 2/2070 • Number of events 2 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Peripheral artery thrombosis	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Peripheral ischaemia	0.02% 1/4151 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Peripheral venous disease	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Shock haemorrhagic	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/2070 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Thrombosis	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.02% 1/4134 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Vascular disorders Varicose ulceration	0.00% 0/4151 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.00% 0/4134 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	0.05% 1/2070 • Number of events 1 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.

Other adverse events

Other adverse events
Measure	FF/UMEC/VI 100/62.5/25 n=4151 participants at risk The eligible participants in this arm received FF/UMEC/VI as a FDC as 100 µcg/62.5µcg/25µcg, QD via a DPI, in the morning, for duration of 52 weeks.	FF/VI 100/25 n=4134 participants at risk The eligible participants in this arm received FF/VI 100µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.	UMEC/VI 62.5/25 n=2070 participants at risk The eligible participants in this arm received UMEC/VI 62.5µcg/25µcg QD via DPI, in the morning for duration of 52 weeks.
Infections and infestations Viral upper respiratory tract infection	12.5% 520/4151 • Number of events 712 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	11.6% 479/4134 • Number of events 658 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	10.7% 222/2070 • Number of events 316 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Upper respiratory tract infection	7.2% 297/4151 • Number of events 401 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	6.8% 283/4134 • Number of events 383 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	5.7% 117/2070 • Number of events 162 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Oral candidiasis	3.9% 161/4151 • Number of events 203 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	3.5% 146/4134 • Number of events 176 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	2.0% 41/2070 • Number of events 50 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Bronchitis	3.4% 142/4151 • Number of events 165 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	2.9% 120/4134 • Number of events 152 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	3.4% 70/2070 • Number of events 83 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Infections and infestations Pneumonia	2.9% 121/4151 • Number of events 131 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	3.1% 127/4134 • Number of events 135 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	2.0% 41/2070 • Number of events 43 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Nervous system disorders Headache	5.6% 233/4151 • Number of events 385 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	4.8% 197/4134 • Number of events 332 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	4.9% 101/2070 • Number of events 139 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Musculoskeletal and connective tissue disorders Back pain	3.5% 146/4151 • Number of events 180 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	3.4% 139/4134 • Number of events 164 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	4.0% 83/2070 • Number of events 101 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.
Respiratory, thoracic and mediastinal disorders Cough	3.5% 145/4151 • Number of events 168 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	2.8% 117/4134 • Number of events 128 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.	2.8% 58/2070 • Number of events 75 • On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52. All AEs and SAEs in the ITT Population were reported. The number of on-treatment deaths are reported from date of first dose of study medication up to the day after the last date of study medication.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER