Trial Outcomes & Findings for A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy (NCT NCT02655016)

NCT ID: NCT02655016

Last Updated: 2026-02-02

Results Overview

Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 733 participants
• Primary outcome timeframe: Up to 34 months
• Results posted on: 2026-02-02

Participant Flow

In this double-blind, randomized, placebo-controlled study, participants with stage III or IV ovarian cancer were randomized to receive either niraparib or placebo in 2:1 ratio. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).

A total of 989 participants were screened, of which 256 participants did not meet eligibility criteria. A total of 733 participants were enrolled and randomized in the study, of which 728 participants received study treatment (4 participants were screen failures after randomization and 1 participant withdrew consent before first dose).

Participant milestones

Measure	Placebo Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Overall Study STARTED	246	487
Overall Study Received Study Treatment	244	484
Overall Study Ongoing With Treatment in the Study	69	177
Overall Study COMPLETED	191	397
Overall Study NOT COMPLETED	55	90

Reasons for withdrawal

Measure	Placebo Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Overall Study Disease progression	6	4
Overall Study Site closed	0	1
Overall Study Death	30	48
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	18	36

Baseline Characteristics

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Baseline characteristics by cohort

Measure	Placebo n=246 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=487 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Total n=733 Participants Total of all reporting groups
Age, Continuous	61.3 Years STANDARD_DEVIATION 10.39 • n=13 Participants	61.1 Years STANDARD_DEVIATION 10.79 • n=15 Participants	61.2 Years STANDARD_DEVIATION 10.65 • n=28 Participants
Sex: Female, Male Female	246 Participants n=13 Participants	487 Participants n=15 Participants	733 Participants n=28 Participants
Sex: Female, Male Male	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants
Race/Ethnicity, Customized White	219 Participants n=13 Participants	436 Participants n=15 Participants	655 Participants n=28 Participants
Race/Ethnicity, Customized Black	2 Participants n=13 Participants	10 Participants n=15 Participants	12 Participants n=28 Participants
Race/Ethnicity, Customized Asian	11 Participants n=13 Participants	14 Participants n=15 Participants	25 Participants n=28 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=13 Participants	1 Participants n=15 Participants	1 Participants n=28 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=13 Participants	1 Participants n=15 Participants	1 Participants n=28 Participants
Race/Ethnicity, Customized Unknown	14 Participants n=13 Participants	25 Participants n=15 Participants	39 Participants n=28 Participants

PRIMARY outcome

Timeframe: Up to 34 months

Population: Intent-to-Treat (ITT) population comprised of all participants who were randomized into the study.

Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.

Outcome measures

Measure	Placebo n=246 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=487 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Progression Free Survival	8.2 Months Interval 7.3 to 8.5	13.8 Months Interval 11.5 to 14.9

SECONDARY outcome

Timeframe: Up to 34 months

Population: ITT Population

Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis.

Outcome measures

Measure	Placebo n=246 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=487 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Overall Survival	NA Months Interval 25.0 to NA indicates median and 95% CI (upper limit) could not be derived, as \<50% of participants experienced the event within the treatment arm.	30.3 Months Interval 30.3 to NA indicates 95% CI (upper limit) could not be derived, as \<75% of participants experienced the event within the treatment arm.

SECONDARY outcome

Timeframe: Up to 34 months

Population: ITT Population

Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented.

Outcome measures

Measure	Placebo n=246 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=487 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Time to First Subsequent Therapy (TFST)	12.0 Months Interval 10.3 to 13.9	18.6 Months Interval 15.8 to 24.7

SECONDARY outcome

Timeframe: Up to 34 months

Population: ITT Population

PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented.

Outcome measures

Measure	Placebo n=246 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=487 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Progression-Free Survival-2 (PFS2)	NA Months NA indicates median and 95% CI could not be derived, as \<25% of participants experienced the event within the treatment arm.	27.2 Months Interval 25.3 to NA indicates 95% CI (upper limit) could not be derived, as \<75% of participants experienced the event within the treatment arm.

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24

Population: ITT Population. Only those participants with data available at the specified time points were analyzed.

FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as (sum of item scores)*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=240 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=479 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)	-0.3 Scores on a scale Standard Error 0.22	-0.4 Scores on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24

Population: ITT Population. Only those participants with data available at the specified time points were analyzed.

The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=243 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=477 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score	0.005 Scores on a scale Standard Error 0.0066	0.016 Scores on a scale Standard Error 0.0046

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24

Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=244 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=479 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) Physical Functioning, n=244,479	2.119 Scores on a scale Standard Error 0.8131	2.013 Scores on a scale Standard Error 0.5735
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) Role Functioning, n=244,479	2.341 Scores on a scale Standard Error 1.2427	1.590 Scores on a scale Standard Error 0.8810
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) Emotional Functioning, n=243,478	-0.011 Scores on a scale Standard Error 1.1218	-0.870 Scores on a scale Standard Error 0.7685
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) Cognitive Functioning, n=243,478	-0.020 Scores on a scale Standard Error 1.2105	-0.842 Scores on a scale Standard Error 0.7952
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) Social Functioning, n=243,478	5.557 Scores on a scale Standard Error 1.2449	4.445 Scores on a scale Standard Error 0.8633

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24

Population: ITT Population. Only those participants with data available at the specified time points were analyzed.

EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 6*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=243 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=478 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30	1.177 Scores on a scale Standard Error 1.0005	1.009 Scores on a scale Standard Error 0.6898

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to Week 24

Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=244 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=480 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Fatigue, n=243,479	-0.082 Scores on a scale Standard Error 1.2394	0.085 Scores on a scale Standard Error 0.8363
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Nausea/Vomiting, n=244,479	1.673 Scores on a scale Standard Error 0.7595	3.115 Scores on a scale Standard Error 0.4828
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Pain, n=244,480	-0.195 Scores on a scale Standard Error 1.2274	0.765 Scores on a scale Standard Error 1.0166
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Dyspnea, n=244,479	0.644 Scores on a scale Standard Error 1.3592	1.347 Scores on a scale Standard Error 0.8518
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Insomnia, n=244,479	2.195 Scores on a scale Standard Error 1.9882	3.478 Scores on a scale Standard Error 1.2791
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Appetite Loss, n=8,30	-0.827 Scores on a scale Standard Error 4.3987	-0.395 Scores on a scale Standard Error 2.3195
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Constipation, n=244,478	-1.147 Scores on a scale Standard Error 1.5793	6.356 Scores on a scale Standard Error 1.0446
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Diarrhea, n=8,30	9.335 Scores on a scale Standard Error 3.8667	-3.340 Scores on a scale Standard Error 2.0136
Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 Financial Difficulties, n=243,475	-5.058 Scores on a scale Standard Error 1.2978	-3.356 Scores on a scale Standard Error 0.9276

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to 34 months

Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal [GI] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=244 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=475 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28) Body Image, n=244,475	10.069 Scores on a scale Standard Error 1.4820	8.488 Scores on a scale Standard Error 1.0138
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28) Sexuality, n=240,471	3.257 Scores on a scale Standard Error 1.1886	3.625 Scores on a scale Standard Error 0.8004
Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28) Attitude to disease/Treatment, n=244,475	12.216 Scores on a scale Standard Error 1.3257	13.660 Scores on a scale Standard Error 0.9309

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and Up to 34 months

Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose).

Outcome measures

Measure	Placebo n=244 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=481 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 Other Chemotherapy Side Effects, n=244,480	-3.023 Scores on a scale Standard Error 0.8358	-2.219 Scores on a scale Standard Error 0.5581
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 Abdominal/GI, n=244,481	0.832 Scores on a scale Standard Error 0.8110	2.185 Scores on a scale Standard Error 0.5703
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 Peripheral Neuropathy, n=244,480	-9.629 Scores on a scale Standard Error 1.3219	-8.217 Scores on a scale Standard Error 0.9295
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 Hormonal/Menopausal Symptoms, n=244,480	-2.521 Scores on a scale Standard Error 1.3074	1.501 Scores on a scale Standard Error 0.8803
Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 Hair Loss, n=242,477	-20.743 Scores on a scale Standard Error 1.3690	-23.363 Scores on a scale Standard Error 0.9821

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 34 months

Population: Safety Population comprised of all participants who received at least 1 dose of study drug. 5 participants (2 participants from Placebo group and 3 participants from Niraparib group) out of 733 participants did not receive any study treatment and thus, were excluded from the Safety Population.

An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.

Outcome measures

Measure	Placebo n=244 Participants Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=484 Participants Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE Any non-SAE	223 Participants	478 Participants
Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE Any SAE	32 Participants	156 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 34 months

Population: ITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.

Blood samples were planned to be collected for assessment of AUC(0-last).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 34 months

Population: ITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.

Blood samples were planned to be collected for assessment of Cmax.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 34 months

Population: ITT Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.

Number of participants with positive HRD test was planned to be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 32 serious events

Other events: 223 other events

Deaths: 31 deaths

Niraparib

Serious events: 156 serious events

Other events: 478 other events

Deaths: 48 deaths

Serious adverse events

Measure	Placebo n=244 participants at risk Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=484 participants at risk Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Blood and lymphatic system disorders Anaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.6% 27/484 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Neutropenia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	12.2% 59/484 • Number of events 65 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Sinus tachycardia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Ventricular tachycardia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Retinal detachment	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal fat apron	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal pain	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal pain upper	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Diarrhoea	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Enteritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Ileus	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Intestinal obstruction	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Intestinal perforation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Nausea	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Small intestinal obstruction	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.9% 14/484 • Number of events 19 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Subileus	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Vomiting	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Fatigue	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Gait disturbance	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders General physical health deterioration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Pyrexia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Cholecystitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Abdominal abscess	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Appendicitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Cellulitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Enterocolitis infectious	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Infected lymphocele	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Infection	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Influenza	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Lung infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Neutropenic sepsis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Pneumonia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Pneumonia fungal	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Pyelonephritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Skin bacterial infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Urinary tract infection	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Hip fracture	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Intentional overdose	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Overdose	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Postoperative hernia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Wound complication	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Hepatic enzyme increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations International normalised ratio increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Neutrophil count decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Platelet count decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.1% 20/484 • Number of events 25 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to breast	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Aphasia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Product Issues Device occlusion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Anxiety	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Confusional state	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Depression	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Insomnia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Mania	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Mental status changes	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Psychotic disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Ureteric stenosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urethral stenosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urinary retention	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Social circumstances Fasting	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Hypertension	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Lymphocele	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).

Other adverse events

Measure	Placebo n=244 participants at risk Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).	Niraparib n=484 participants at risk Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
Eye disorders Photopsia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Pain	2.5% 6/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.3% 16/484 • Number of events 17 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Ulcer	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Anaemia	17.6% 43/244 • Number of events 83 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	63.2% 306/484 • Number of events 921 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Leukopenia	5.3% 13/244 • Number of events 27 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	11.8% 57/484 • Number of events 145 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Lymphadenopathy	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 40 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Macrocytosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Neutropenia	6.6% 16/244 • Number of events 32 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	26.0% 126/484 • Number of events 366 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Blood and lymphatic system disorders Thrombocytopenia	3.7% 9/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	43.4% 210/484 • Number of events 549 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Angina pectoris	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Atrial fibrillation	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Cardiac failure	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Conduction disorder	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Coronary artery disease	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Metabolic cardiomyopathy	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Palpitations	2.0% 5/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.1% 39/484 • Number of events 45 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Sinus tachycardia	1.2% 3/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 17 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Tachyarrhythmia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Tachycardia	2.5% 6/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.2% 25/484 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Cardiac disorders Ventricular extrasystoles	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Cerumen impaction	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Deafness	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Ear congestion	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Ear discomfort	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Ear haemorrhage	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Ear pain	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Ear pruritus	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders External ear pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Hypoacusis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Meniere's disease	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Motion sickness	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Paraesthesia ear	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Tinnitus	1.6% 4/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.3% 11/484 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Vertigo	2.5% 6/244 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.7% 13/484 • Number of events 13 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Vertigo positional	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Ear and labyrinth disorders Vestibular disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Endocrine disorders Hyperparathyroidism	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Endocrine disorders Hyperthyroidism	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Endocrine disorders Hypothyroidism	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Endocrine disorders Thyroid cyst	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Endocrine disorders Thyroid mass	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Age-related macular degeneration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Blepharospasm	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Cataract	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Cataract nuclear	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Conjunctival haemorrhage	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Conjunctivitis allergic	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Diplopia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Dry eye	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.3% 11/484 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eye disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eye haemorrhage	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eye oedema	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eye pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eye swelling	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eyelid oedema	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Eyelid sensory disorder	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Hypermetropia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Lacrimation increased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Myopia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Ocular discomfort	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Ocular hyperaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Photophobia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Retinal exudates	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Retinal haemorrhage	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Scleral disorder	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Vision blurred	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Visual acuity reduced	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Visual impairment	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Eye disorders Vitreous floaters	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal discomfort	4.5% 11/244 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.1% 15/484 • Number of events 19 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal distension	12.3% 30/244 • Number of events 36 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	6.6% 32/484 • Number of events 36 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal hernia	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal mass	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal pain	30.3% 74/244 • Number of events 102 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	21.7% 105/484 • Number of events 146 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal pain lower	5.3% 13/244 • Number of events 17 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.1% 15/484 • Number of events 16 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal pain upper	8.6% 21/244 • Number of events 26 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.5% 41/484 • Number of events 59 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abdominal tenderness	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Abnormal faeces	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Aerophagia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Anal fissure	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Anal haemorrhage	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Anal incontinence	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Anal pruritus	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Anorectal discomfort	0.82% 2/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Aphthous ulcer	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Ascites	3.3% 8/244 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Cheilitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Chronic gastritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Coeliac disease	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Constipation	18.9% 46/244 • Number of events 52 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	39.0% 189/484 • Number of events 262 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Defaecation urgency	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Dental caries	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Diarrhoea	22.5% 55/244 • Number of events 82 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	18.8% 91/484 • Number of events 132 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Diverticulum intestinal	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Dry mouth	2.5% 6/244 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.3% 40/484 • Number of events 46 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Dyspepsia	5.7% 14/244 • Number of events 16 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	7.0% 34/484 • Number of events 43 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Dysphagia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Epigastric discomfort	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Eructation	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Faecaloma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Faeces discoloured	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Faeces soft	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Flatulence	2.9% 7/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.5% 17/484 • Number of events 20 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Frequent bowel movements	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastric disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastritis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastritis erosive	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastrointestinal motility disorder	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gastrooesophageal reflux disease	2.9% 7/244 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.2% 25/484 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gingival bleeding	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Gingival pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Glossitis	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Glossodynia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Haematochezia	1.2% 3/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Haemorrhoids	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Hiatus hernia	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Intestinal mass	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Intestinal obstruction	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Large intestine polyp	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Lip blister	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Lip disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Lip swelling	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Melaena	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Mouth ulceration	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Nausea	27.5% 67/244 • Number of events 100 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	57.4% 278/484 • Number of events 448 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Noninfective gingivitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Odynophagia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Oesophagitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Oral contusion	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Oral mucosal blistering	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Oral mucosal discolouration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Oral pain	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Pancreatic disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Paraesthesia oral	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Proctalgia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Rectal discharge	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Rectal haemorrhage	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Rectal tenesmus	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Regurgitation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Retching	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Salivary duct stenosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Salivary gland calculus	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Small intestinal obstruction	0.82% 2/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Stomatitis	1.6% 4/244 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.3% 16/484 • Number of events 18 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Swollen tongue	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Tongue coated	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Tooth disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Tooth impacted	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Toothache	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Umbilical hernia	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Gastrointestinal disorders Vomiting	11.5% 28/244 • Number of events 34 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	22.3% 108/484 • Number of events 153 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Adhesion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Asthenia	12.7% 31/244 • Number of events 47 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	16.1% 78/484 • Number of events 138 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Axillary pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Catheter site bruise	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Catheter site haematoma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Catheter site pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Catheter site rash	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Catheter site vesicles	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Chest discomfort	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Chest pain	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Chills	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Cyst	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Discomfort	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Early satiety	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Facial pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Fatigue	29.5% 72/244 • Number of events 101 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	34.7% 168/484 • Number of events 242 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Feeling abnormal	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Feeling hot	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Gait disturbance	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders General physical health deterioration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Generalised oedema	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Hernia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Hernia pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Induration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Influenza like illness	4.5% 11/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.1% 15/484 • Number of events 22 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Injection site reaction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Local swelling	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Malaise	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Mass	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Mucosal dryness	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Mucosal inflammation	2.5% 6/244 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.8% 23/484 • Number of events 29 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Non-cardiac chest pain	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.7% 13/484 • Number of events 15 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Oedema peripheral	4.5% 11/244 • Number of events 19 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	6.2% 30/484 • Number of events 35 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Peripheral swelling	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Pyrexia	6.1% 15/244 • Number of events 17 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.5% 41/484 • Number of events 47 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Secretion discharge	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Sensation of foreign body	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Suprapubic pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Swelling	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Unevaluable event	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Vessel puncture site bruise	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
General disorders Vessel puncture site haematoma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Biliary colic	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Biliary dilatation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Hepatic pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Hepatic steatosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Hepatitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Hepatitis toxic	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Hyperbilirubinaemia	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Hepatobiliary disorders Liver disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Immune system disorders Contrast media allergy	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Immune system disorders Contrast media reaction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Immune system disorders Hypersensitivity	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Immune system disorders Seasonal allergy	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Abdominal infection	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Acute sinusitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Anal abscess	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Angular cheilitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Arthritis infective	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Bronchitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 13 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Candida infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Catheter site cellulitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Cellulitis	0.41% 1/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Clostridium difficile colitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Conjunctivitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Cystitis	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Device related infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Diverticulitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Ear infection	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Eye infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Folliculitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Fungal infection	1.6% 4/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Fungal skin infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Furuncle	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Gastric infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Gastroenteritis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Gastroenteritis viral	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Gastrointestinal candidiasis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Genital herpes	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Gingivitis	0.41% 1/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Helicobacter gastritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Herpes zoster	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Hordeolum	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Influenza	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Laryngitis	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Localised infection	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Lung infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Lymphangitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Mastitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Medical device site infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Mucosal infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Nail infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Nasopharyngitis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Onychomycosis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Ophthalmic herpes simplex	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Oral fungal infection	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Oral herpes	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Oral infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Otitis externa	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Otitis media	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Paronychia	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Pharyngitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Pneumonia	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Pyelonephritis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Respiratory tract infection	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Respiratory tract infection viral	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Rhinitis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.9% 9/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Sepsis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Shigella infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Sialoadenitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Sinusitis	2.9% 7/244 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.1% 15/484 • Number of events 27 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Skin candida	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Skin infection	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Soft tissue infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Tinea pedis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Tonsillitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Tooth abscess	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Tooth infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Tracheitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Upper respiratory tract infection	7.4% 18/244 • Number of events 22 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.8% 28/484 • Number of events 31 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Urinary tract infection	7.8% 19/244 • Number of events 25 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	9.1% 44/484 • Number of events 48 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Vaginal infection	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Viral infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Viral upper respiratory tract infection	10.2% 25/244 • Number of events 40 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	10.1% 49/484 • Number of events 55 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Vulvitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Vulvovaginal candidiasis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Animal bite	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Bone contusion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Chest injury	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Compression fracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Contusion	1.2% 3/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.5% 22/484 • Number of events 29 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Fall	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 14 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Foot fracture	0.82% 2/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Head injury	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Incision site pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Incision site swelling	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Incisional hernia	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Joint dislocation	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Laceration	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Ligament sprain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Limb injury	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Mallet finger	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Meniscus injury	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Muscle injury	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Muscle strain	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Postoperative hernia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Procedural pain	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Procedural site reaction	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Radius fracture	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Rib fracture	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Scar	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Skin abrasion	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Stoma complication	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Stoma site discharge	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Stoma site inflammation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Sunburn	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Upper limb fracture	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Vascular access malfunction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Wound	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Wound complication	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Alanine aminotransferase	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Alanine aminotransferase increased	6.1% 15/244 • Number of events 21 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.7% 42/484 • Number of events 67 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Amylase increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Aspartate aminotransferase	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Aspartate aminotransferase increased	4.1% 10/244 • Number of events 16 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.9% 43/484 • Number of events 78 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Bilirubin conjugated increased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood alkaline phosphatase	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood alkaline phosphatase increased	2.5% 6/244 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.7% 42/484 • Number of events 66 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood bilirubin increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 13 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood calcium increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood chloride increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood cholesterol increased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood creatine increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood creatinine increased	4.1% 10/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	11.4% 55/484 • Number of events 96 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood glucose decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood glucose increased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood lactate dehydrogenase increased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood magnesium decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood potassium increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood pressure increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood sodium decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Blood urea increased	0.41% 1/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Bone density decreased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Carbohydrate antigen 125 increased	4.1% 10/244 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Electrocardiogram QT prolonged	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Eosinophil count decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Gamma-glutamyltransferase increased	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.3% 11/484 • Number of events 21 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Haematocrit decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Haemoglobin decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Heart rate increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.9% 9/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Hepatic enzyme increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Intraocular pressure increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Lipase increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Lymphocyte count decreased	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.2% 25/484 • Number of events 43 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Mean cell volume increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Monocyte count decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Monocyte count increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Neutrophil count decreased	2.0% 5/244 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	16.9% 82/484 • Number of events 207 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Neutrophil count increased	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Platelet count decreased	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	26.7% 129/484 • Number of events 338 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Platelet count increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Protein total decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Red blood cell count decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Sputum abnormal	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Vitamin D decreased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Weight decreased	1.6% 4/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.1% 20/484 • Number of events 27 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations Weight increased	7.8% 19/244 • Number of events 30 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.5% 17/484 • Number of events 24 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations White blood cell count decreased	3.3% 8/244 • Number of events 16 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	15.3% 74/484 • Number of events 205 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Investigations White blood cell count increased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Cachexia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Cell death	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Decreased appetite	8.2% 20/244 • Number of events 21 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	19.0% 92/484 • Number of events 112 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Dehydration	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Glucose tolerance impaired	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyperalbuminaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypercalcaemia	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.9% 9/484 • Number of events 14 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypercholesterolaemia	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyperglycaemia	2.5% 6/244 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.9% 19/484 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyperkalaemia	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyperproteinaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyperuricaemia	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypoalbuminaemia	1.2% 3/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 13 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypocalcaemia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypochloraemia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypoglycaemia	0.82% 2/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypokalaemia	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.2% 25/484 • Number of events 37 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypomagnesaemia	4.9% 12/244 • Number of events 18 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	7.9% 38/484 • Number of events 58 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hyponatraemia	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.9% 19/484 • Number of events 35 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Increased appetite	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Iron deficiency	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Magnesium deficiency	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Polydipsia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Arthralgia	19.3% 47/244 • Number of events 77 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	17.6% 85/484 • Number of events 116 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Arthritis	1.6% 4/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Back pain	9.8% 24/244 • Number of events 29 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	13.2% 64/484 • Number of events 84 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Bone disorder	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Bone pain	1.6% 4/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Costochondritis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Extremity contracture	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Flank pain	1.6% 4/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Groin pain	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Hypercreatinaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Joint instability	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Joint stiffness	1.6% 4/244 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Limb discomfort	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Muscle contracture	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Muscle spasms	5.7% 14/244 • Number of events 25 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.9% 19/484 • Number of events 24 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Muscle tightness	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Muscular weakness	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 15 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.7% 9/244 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 17 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.3% 8/244 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 15 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.41% 1/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Myalgia	5.3% 13/244 • Number of events 18 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	7.4% 36/484 • Number of events 49 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Myalgia intercostal	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Neck pain	2.9% 7/244 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 13 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Osteochondrosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Osteopenia	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Osteoporosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.9% 14/484 • Number of events 15 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Pain in extremity	6.6% 16/244 • Number of events 20 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	7.9% 38/484 • Number of events 53 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Pain in jaw	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Spinal pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Tendonitis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Musculoskeletal and connective tissue disorders Trigger finger	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.41% 1/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal neoplasm	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Amnesia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Aphasia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Aphonia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Aura	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Balance disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Burning sensation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Carpal tunnel syndrome	1.2% 3/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Cognitive disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Disturbance in attention	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Dizziness	10.7% 26/244 • Number of events 30 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	14.7% 71/484 • Number of events 96 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Dizziness postural	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Dysaesthesia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Dysgeusia	4.1% 10/244 • Number of events 13 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.2% 25/484 • Number of events 34 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Dyskinesia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Facial nerve disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Headache	14.8% 36/244 • Number of events 46 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	26.0% 126/484 • Number of events 190 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Hemiparesis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Hypoaesthesia	2.5% 6/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Loss of consciousness	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Memory impairment	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Mental impairment	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Migraine	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Motor dysfunction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Neuralgia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Neuropathy peripheral	6.1% 15/244 • Number of events 18 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	6.4% 31/484 • Number of events 38 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Neurotoxicity	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Paraesthesia	3.3% 8/244 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.3% 11/484 • Number of events 20 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Peripheral motor neuropathy	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Peripheral sensory neuropathy	3.3% 8/244 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.7% 18/484 • Number of events 21 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Polyneuropathy	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Presyncope	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Radiculopathy	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Restless legs syndrome	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Sciatica	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.9% 9/484 • Number of events 10 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Seizure	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Sinus headache	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Somnolence	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Speech disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Syncope	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Tension headache	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Transient global amnesia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Transient ischaemic attack	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Nervous system disorders Tremor	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Agitation	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Anxiety	7.8% 19/244 • Number of events 24 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	8.9% 43/484 • Number of events 53 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Confusional state	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Depressed mood	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Depression	4.1% 10/244 • Number of events 14 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.4% 26/484 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Dysphoria	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Emotional disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Genito-pelvic pain/penetration disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Hallucination	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Hallucination, olfactory	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Initial insomnia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Insomnia	14.3% 35/244 • Number of events 37 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	24.6% 119/484 • Number of events 162 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Irritability	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Libido decreased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Libido increased	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Mania	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Mood swings	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Nervousness	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Nightmare	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Panic attack	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Psychotic disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Restlessness	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Sleep disorder	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Stress	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Psychiatric disorders Suicidal ideation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Acute kidney injury	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Azotaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Bladder discomfort	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Bladder pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Bladder spasm	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Chronic kidney disease	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Cystitis interstitial	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Cystitis noninfective	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Dysuria	4.1% 10/244 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.3% 21/484 • Number of events 22 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Haematuria	2.5% 6/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Leukocyturia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Micturition disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Micturition urgency	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Nephritis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Nephropathy	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Nocturia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Pollakiuria	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.3% 11/484 • Number of events 11 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Polyuria	0.41% 1/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Proteinuria	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Renal colic	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Renal failure	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Renal pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urethral pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urinary incontinence	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urinary retention	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urinary tract obstruction	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urinary tract pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Renal and urinary disorders Urine odour abnormal	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Atrophic vulvovaginitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Breast calcifications	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Breast discharge	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Breast pain	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Breast tenderness	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Coital bleeding	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Dyspareunia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Female genital tract fistula	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Genital paraesthesia	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Genital swelling	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Menopausal symptoms	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Metrorrhagia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Pelvic pain	2.5% 6/244 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Perineal pain	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Uterine polyp	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vaginal discharge	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vaginal haemorrhage	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vaginal mucosal blistering	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vulvovaginal burning sensation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vulvovaginal dryness	2.5% 6/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Reproductive system and breast disorders Vulvovaginal pruritus	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Asthma	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Cough	14.3% 35/244 • Number of events 45 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	15.3% 74/484 • Number of events 92 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Dry throat	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.3% 30/244 • Number of events 33 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	18.2% 88/484 • Number of events 129 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.5% 17/484 • Number of events 18 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Epistaxis	1.2% 3/244 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.8% 23/484 • Number of events 24 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Hiccups	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 9/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.3% 21/484 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.4% 18/244 • Number of events 19 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.5% 22/484 • Number of events 24 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Productive cough	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.9% 14/484 • Number of events 16 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.82% 2/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.9% 9/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Respiratory, thoracic and mediastinal disorders Wheezing	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Acne	0.41% 1/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Alopecia	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Dermatitis contact	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Dry skin	4.5% 11/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	3.9% 19/484 • Number of events 21 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Ecchymosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Eczema	0.82% 2/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Erythema	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.2% 6/484 • Number of events 9 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Erythema dyschromicum perstans	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Hair texture abnormal	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Hirsutism	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Hyperhidrosis	1.6% 4/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.7% 8/484 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Hyperkeratosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Hypertrichosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Ingrown hair	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Macule	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Madarosis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Nail discolouration	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Nail growth abnormal	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Night sweats	1.2% 3/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.0% 5/484 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Onychoclasis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Onychomadesis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Papule	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	5.8% 28/484 • Number of events 29 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	6.0% 29/484 • Number of events 35 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Pityriasis	0.41% 1/244 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Pruritus	7.8% 19/244 • Number of events 21 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.7% 13/484 • Number of events 18 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Pruritus generalised	2.0% 5/244 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Psoriasis	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Purpura	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Rash	3.3% 8/244 • Number of events 12 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	4.8% 23/484 • Number of events 29 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Rash generalised	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Rash macular	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Rash maculo-papular	3.3% 8/244 • Number of events 8 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	2.5% 12/484 • Number of events 14 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Rosacea	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Scar pain	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Sebaceous gland disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin exfoliation	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin fissures	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin reaction	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Solar dermatitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Solar lentigo	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.83% 4/484 • Number of events 4 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Surgical and medical procedures Astringent therapy	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Surgical and medical procedures Tooth extraction	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.00% 0/484 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Blood pressure fluctuation	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Embolism	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Flushing	0.82% 2/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Haematoma	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	1.4% 7/484 • Number of events 7 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Hot flush	8.2% 20/244 • Number of events 20 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	11.2% 54/484 • Number of events 64 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Hyperaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Hypertension	7.0% 17/244 • Number of events 28 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	16.7% 81/484 • Number of events 142 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Hypotension	0.82% 2/244 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Lymphocele	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Lymphoedema	1.2% 3/244 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Orthostatic hypotension	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Pallor	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.41% 2/484 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Peripheral ischaemia	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Phlebitis	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Thrombosis	0.00% 0/244 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.21% 1/484 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).
Vascular disorders Varicose vein	0.41% 1/244 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).	0.62% 3/484 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were reported from start of study treatment (Day 1) and up to month 34 (primary analysis) Non-SAEs and SAEs were presented for Safety Population. 5 participants out of 733 participants did not receive any study treatment and were excluded from the Safety Population. The results presented are based on the primary analysis up to month 34. Data collection is still on-going and additional results will be provided after study completion (7 years).

Additional Information

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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.
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